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August 2023

Volume 23, Issue 8

The U.S. Food and Drug Administration’s (FDA) MedSun program provides this monthly newsletter to inform patients and patient advocates about FDA-related information on a variety of topics, including new products the FDA has authorized for marketing, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

The MedSun program, launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes, and home health facilities around the United States. MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun uses a secure, online reporting system for reporting problems with the use of medical devices and plays a critical role in the FDA’s postmarket surveillance efforts.

Recalls

• Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms 7/31/23
• GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings 7/28/23
• Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism 7/26/23
• Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy 7/18/23
• Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction 7/17/23
• Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop 7/14/23
• NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates 7/13/23
• Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients 7/11/23
• Quick link to 2023 Medical Device Recalls

Safety Communications

• Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices 7/17/23

Letters to Health Care Providers

• UPDATE: Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration 7/31/23
• UPDATE: Intended Use of Imaging Software for Intracranial Large Vessel Occlusion 7/26/23
• Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel 7/19/23
• UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality 7/11/23

Guidance Documents

• Final: Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
• Draft: Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act
• Draft: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder

Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web pages Make Processes Clearer, Easier to Understand

The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and Medicaid Services (CMS) is responsible for many aspects of the CLIA program, including the certification of clinical laboratories, the FDA is responsible for categorizing the complexity of tests, and the categorization is then used to determine which laboratories can perform which tests.

Learn more about: FDA’s role under the CLIA program FDA’s guidance documents on the FDA’s CLIA processes FDA’s process for test categorization Submitting a CLIA waiver application to the FDA

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/or edited for clarity.

Type: Hemostatic metal clip for the GI tract

Manufacturer: Boston Scientific Corp.
Brand: Resolution 360 ULTRA Clip
Model #: M00521400
Lot #: 30470948
Cat #: M00521400

Event Description: The patient came into the gastrointestinal (GI) lab for a GI bleed. When scoping, a bleeding duodenal ulcer was found. The doctor attempted to apply a Boston scientific Resolution 360 ULTRA clip. When the clip was deployed, it broke and was left in a fully open position. The defect was then clipped with a second clip. However, the broken clip left exposed sharp edges, and we needed to retrieve it to prevent it from causing damage. We attempted to use a third clip to close the failed clip. We also attempted to use a Roth Net retriever to remove the broken clip, but it became entangled in the net and could have potentially caused esophageal damage while being removed. The doctor eventually was able to remove the clip. I have concerns that if this was a brisker bleed it could have caused additional complications. We had to use multiple devices to remove this clip adding expense for the patient.

Type: Lift, Patient, Non-ac-powered

Manufacturer: EZ Way, Inc.
Brand: EZ Lift
Model #: 8002

Event Description: A Bariatric EZ Stand was difficult to maneuver while attempting to pivot a patient from the chair to the bed. During the attempt to transfer the patient, the patient’s legs weakened, causing the patient’s arms to fall into the sling of the EZ Stand. The physical therapist was assisting the patient while using the EZ stand. It was reported that patient "buckled", leaving the patient suspended by the armpits in the EZ stand. The physical therapist was present and assisting appropriately. Five days later, the patient became hemodynamically unstable and required Intensive Care Unit (ICU) admission for severe bleeding into the axillary area. It is believed that this is a direct result of the EZ stand incident. The patient received multiple blood product transfusions, Interventional Radiology (IR) intervention, and ultimately surgery to stop the very severe bleed.

Type: Ring, Annuloplasty

Manufacturer: Medtronic, Inc.
Brand: SimuPlus Flexible Annuloplasty Band
Cat #: 7700FB
Other #: Size 28

Event Description: The surgeon was prepared to complete a mitral valve repair and selected the Medtronic SimuPlus Flexible Annulopasty Band. As the surgeon went to place the band in place and sew it in, the applicator handle disconnected from the handpiece, and it could not be placed successfully. The surgeon then decided to complete a full mitral valve replacement.

Device 1:

Type: Set, Administration, Intravascular

Manufacturer: Baxter Healthcare Corp.
Brand: Clearlink/Duo-Vent
Model #: 2H7462
Lot #: R19I10108, R20G15033, R21K50079, R21F16032
Cat #: 2H7462

Device 2:

Type: Set, Administration, Intravascular

Manufacturer: Baxter Healthcare Corp.
Brand: Clearlink/Continu-Flo/Duo-Vent
Model #: 2R8538
Lot #: DR21J30031, DR21I07062, DR21L13024
Cat #: 2R8538

Device 3 & 4:

Type: Set, Blood Transfusion

Manufacturer: Baxter Healthcare Corp.
Brand: Clearlink
Model #: 2C8750; 2R8403
Lot #: DR20I28040; unknown
Cat #: 2C8750; 2R8403

Event Description: In the last nine months, this facility has been noting discolored IV tubing from Baxter, this has occurred with 4 different types of tubing sets. The discoloration impacts clinical practice as it makes it difficult for the RN administering the IV solution/medication to see the fluid in the tubing, assess for air bubbles, particulate, etc. Infection Control and Clinical staff have expressed concern utilizing the discolored tubing while caring for the institute's high-risk patient population as they fear the tubing is contaminated. The discoloration was reported to Baxter and product return, or exchange was requested, but refused. Baxter states the tubing is safe to use as discoloration is from the sterilization process. However, Baxter has not provided additional details requested by hospital leadership as to why only some sets are affected by the sterilization process, etc. This facility has also noted there is now a disclaimer on some IV sets from Baxter stating discolored sets are safe to use, but the disclaimer is not on all sets. 2H7462 Secondary Tubing Set: 2,309 sets disposed 2R8538 Primary Tubing Set: 588 cases quarantined 2C8750 Blood Administration Set: 52 sets disposed 2R8403 Short Primary Set: 158 sets disposed

Type: Set, administration, intravascular

Manufacturer: Becton Dickinson
Brand: BD Microclave Stabilized Extension Set
Lot #: 9453943
Cat #: 201-0016

Event Description: This issue has been intermittently happening over the past week. The VelanoVascular EXT stabilized extension set has a defect causing blood to pour out when it's hooked up to IV catheter upon initial insertion. Some supplies were kept and provided to management, so additional lot numbers may be involved. I have been finding two to three devices per day with this issue while I have been in Charge and doing IV starts. This is a potential safety issue because it unexpectedly exposes staff to blood and may cause the patient’s IV site to malfunction, which would result in the need to restart the IV. For this patient, it was a very difficult IV start requiring IV Ultrasound placement.

Neonatal and Pediatric Reports

These reports describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as those who are 21 years of age or younger (that is, from birth through the twenty-first year of life, up to but not including the twenty-second birthday) at the time of the diagnosis or treatment.

Type: Pump, Infusion

Manufacturer: Smiths Medical Asd, Inc.
Brand: Medfusion

Event Description: A syringe pump was in use infusing fentanyl drip on an intubated patient. The syringe pump started beeping and screen displayed: "Enter Biomed passcode - system failure". The PICU (pediatric intensive care unit) had five syringe pumps with same failure on previous calendar day, but these pumps failed during setup and not while in use. If this were to occur with a vasopressor drip running, could be very detrimental to patients. Biomed checked the pumps and found no issues.

Type: Apparatus, Exhaust, Surgical

Manufacturer: Stryker Corp
Brand: Neptune
Model #: Neptune 3 Rover
Ref #: 0703001000

Event Description: The Neptune 3 Rover waste management system by Stryker had a strong foul electrical smell in the OR during a cardiovascular case. The power circuit board had a partially melted fuse holder. The unit did not lose power, there was no smoke, and the fuse did not blow. The unit was turned off and removed from the room. The repair included replacing the PC board and the ACPD. These parts were returned to Stryker Engineering for diagnostics. Since this event we have had one more failure of these same components in a different Rover. There was no patient harm in either case.

FDA Meetings, Conferences and Workshops

• Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting 8/22-23/23
• 2023 Scientific Computing Days 9/12-13/23
• Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder 9/14/23

Links to FDA CDRH Databases and Other Information Sources

• Database of registered medical devices and manufacturers (Reg & Listing)
• Global Unique Device Identification Database (GUDID)
• Medical Device Recalls database
• Medical Device Safety
• MedSun: Medical Product Safety Network

Contact Us

Email: MedSun@fda.hhs.gov
Telephone: 800-859-9821
Fax: 800-859-1292

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