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June 2024

Volume 24, Issue 6

The U.S. Food and Drug Administration’s (FDA) MedSun program provides this monthly newsletter to inform patients and patient advocates about FDA information on medical device related topics. The MedSun program, launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), uses a secure online reporting system to receive medical device adverse event reports from a network of over 300 clinical facilities across the United States. MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products and play a critical role in the FDA’s postmarket surveillance efforts.

Safety Communications

• Update: Evaluating Plastic Syringes Made in China for Potential Device Failures 5/23/24
• Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication 5/13/24

Letters to Health Care Providers

• Safety and Quality Concerns with Getinge Cardiovascular Devices 5/8/24

Highlighted Recalls

• Vyaire Medical Recalls the Twin Tube Due to The Potential of the Nozzle Separating During Patient Use 5/23/24
• Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices 5/22/24
• Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff  5/15/24
• Update: Draeger Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power 5/15/24
• Philips Respironics Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction 5/13/24
• MEGADYNE Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT Pediatric Patient Return Electrode 5/10/24
• Route 92 Medical Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band 5/10/24
• Tandem Diabetes Care Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion 5/8/24
• Quick Link to Medical Device Recalls

Guidances

• Draft: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
• Draft: Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency
• Final: Remanufacturing of Medical Devices
• Final: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry

FDA News Release

• Tips to Help Charge Medical Devices Safely and Avoid Overheating
• FDA Qualifies Two New Medical Device Development Tools (MDDT): Assessment of Intraocular Lens Implant Symptoms (AIOLIS) Instrument and Apple Atrial Fibrillation History Feature
• FDA Office of Women’s Health Celebrates 30 Years of Protecting and Advancing Women’s Health

Highlighted Reports

The reports that follow represent a cross section of device related events sent by MedSun Representatives during the prior month. The reports are presented as submitted by MedSun Representatives and in some instances, have been summarized and edited for clarity.

Type: Tubes, gastrointestinal (and accessories) Manufacturer: Xeridiem Medical Devices Brand: Entuit gastrostomy balloon retention feeding tube with Enfit connection Model: G44783 Lot: 11250C013 Cat: SBRD-18-ENF UDI-DI: 00827002447837 Event Description: The patient was accidentally given a fluid rinse through the balloon treatment opening (port) of the feeding tube causing the balloon to burst. The patient complained of pain and felt a “pop” sensation. A stat CT confirmed a balloon burst. The patient was urgently taken to the operating room for exploratory stomach surgery and treatment. There are three ports on the device: one is labeled “5-10mL” (not clearly labeled as balloon port), one is labeled “MED,” and one is labeled “FEED.” The IV tubing for the fluid rinse was able to be attached to the balloon port.

Type: Neurological stereotaxic instrument

Manufacturer: Medtronic Navigation, Inc.
Brand: StealthStation S8 platform

Event Description: Staff placed the AxiEM stealth tracker on the patient’s forehead in standard fashion and secured with tape. Stealth registration was performed and accurate. Staff checked for device accuracy at the start of the case and before drilling into the skull: it was fine. Somewhere during the case, the tracker shifted, and the navigation was off. This resulted in the physician placing the shunt into an area beneath the brain that drains blood from the back of the head (transverse sinus) rather than one of the fluid-filled spaces in the center of the brain (ventricle). The physician then had to do a full removal of the skull covering the brain (craniotomy) and cut down to control and stop the bleeding. Once controlled, the physician was able to retrace the stealth and place the shunt. The patient was then sent for imaging and the physician was comfortable that the bleeding had stopped.

Type: System, tomography, computed, emission

Manufacturer: Spectrum Dynamics Medical, Inc.
Brand: D-Spect Cardio
Model: 004
Cat: 8010120-01
UDI-DI: 07290108670066

Event Description: A patient with left sided weakness on one side of the body and no trunk control was at the clinic for an imaging test showing blood flow into the heart muscle, both at rest and during activity. The patient was successfully transferred to the scanner by multiple staff. At the conclusion of testing, the technician turned away from the patient to view the computer and to confirm the quality of the images. During this time, the patient’s left upper torso fell from the camera to the floor within the open space of the camera. The patient reported no pain and declined being seen by a provider. Days later, the patient’s wife called stating that the patient was bruised, and that pain had developed. It was identified that the patient had a closed displaced left collarbone fracture, multiple closed rib fractures, and bruised left torso. Patient canceled scheduled surgery procedure due to pain from injuries. The camera did not come with any protective devices that could be used for patients with limited ability to participate in their care. We reached out to the manufacturer to ask whether they have anything that could be used to secure the patient to the chair, and they stated that they do sell narrow straps that can be used. They referred us to the sales manager, who indicated that they have chest straps and leg straps available. When we requested additional information (pictures and specifications of the straps), the sales manager stated that there are straps that are now part of the standard configuration and that they were sent to another location that is part of our health system’s last order. We requested a new manual to ensure appropriate use, training, and infection prevention practices, and the sales manager stated that they do not have an updated manual with the straps in it. The last communication with the manufacturer is that they are looking for documentation on the straps.

Type: Syringe, antistick

Manufacturer: Retractable Technologies, Inc.
Brand: VanishPoint
Model: 10151
Cat: 10151
UDI-DI: 00613703101501
Type: Needle, hypodermic, single lumen
Brand: EasyPoint
Model: 82011, 85231, 85291
Lot: K201207, K201113, K210105, K211209, K211201 
Cat: 82011, 85231, 85291
UDI-DI: 00613703820105, 00613703852304, 00613703852908

Event Description: Over the past two years, our facility has had a significant number of issues with EasyPoint needles. It is our opinion that they are unsafe for medical professionals and patients. The issues we have had include needles not retracting, blood spray when the needle is retracted, needles popping off syringes when attempting retraction, syringes popping out, dull needles failing to pierce the skin and causing patients pain, needles bending when drawing up medications, abnormal curving of the needle tips, syringe/needle completely falling apart when retracted, protective caps falling off when the device is removed from packaging, needles having connection issues (for example not tightening), and leaking at the hub. We have gone through the proper channels, had Retractable Technology, Inc. educators out to meet with staff, sent back defective needles, and still do not have resolution. Our Supply Chain department has over 55 reports, not including additional unreported events.

Type: Warmer, thermal, infusion fluid

Manufacturer: Belmont Medical Technologies
Brand: Rapid Infuser Ri-2, 120v, 1000ml/min
Model: 903-00037
UDI-DI: 10896128002630

Event Description: The Emergency Care Research Institute (ECRI) published an Exclusive Hazard Report on rapid infusers and hyperthermia pumps (devices designed to warm and administer large amounts of fluid or blood) because the devices may not work due to valve wand motor looseness. Our Biomedical Engineering team (biomed) reviewed the ECRI report and reported that this facility owns a total of seven Belmont Rapid Infusers FMS 2000, RI-2. Biomed began inspecting the units and found one unit with the lower left hand screw broken off. The lower right hand screw hole is enlarged. Belmont technical support was not sure how to handle this. They said we were the first ones to request repair. This unit has not had any issues report recently. However, these devices deliver lifesaving fluids and blood at a potentially very high rate, and interruption of the fluids or blood delivery can cause patient injury or death, so it will be pulled from service. In the interim, we will continue to communicate with the Belmont technical support team on the need for a loaner while they promptly repair our unit.

Neonatal and Pediatric Reports

Announcements

NIH and FDA Seek Comment on Draft Glossary of Clinical Research Terms Related to Innovative Clinical Trial Design

The National Institutes of Health (NIH) and the FDA released a request for information with a draft glossary of clinical research terms related to innovative clinical trial design, including studies using real-world data to generate real-world evidence. The draft glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to characterize clinical research more uniformly. Please see the draft glossary for more information. NIH and the FDA will accept comments on the draft glossary until June 24. Send questions about this draft glossary to SciencePolicy@mail.nih.gov.

FDA Guidance Clarifies the Difference Between Remanufacturing and Servicing Medical Devices

The FDA announced a webinar will be held on June 27 for those interested in learning more about the final guidance Remanufacturing of Medical Devices. This final guidance is a part of the FDA’s ongoing efforts to help distinguish between remanufacturing and servicing. It clarifies whether activities performed on devices are likely "remanufacturing," which differs from servicing activities, such as maintenance and repair. Additionally, the guidance recommends information to be included in the labeling of reusable medical devices to help ensure their continued quality and safety during servicing.

FDA Meetings, Conferences, and Workshops

• Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances 6/5/24
• FDA Oncology Center of Excellence Presents Conversations on Cancer, 4th Annual National Black Family Cancer Awareness Week, Engaging the Generations, #BlackFamCan 6/13/24
• FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference 6/18/24
• 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop 6/25/24
• Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Lifecycle 6-26-24 – 6/27/24
• Final Guidance: Remanufacturing of Medical Devices 6/27/24

Links to FDA CDRH Databases and Other Information Sources

• Database of Registered Medical Devices and Manufacturers
• Access Global Unique Device Identification Database (GUDID)
• Medical Device Safety
• MedSun: Medical Product Safety Network
• Medical Device Recalls

Contact Us

Email: MedSun@fda.hhs.gov
Telephone: 800-859-9821

U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993