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May 2024

Volume 24, Issue 5

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

• FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication 4/22/24
• Update: Evaluating Plastic Syringes Made in China for Potential Device Failures 4/25/24

Recalls

• SonarMed Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty 4/29/24
• SonarMed Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip 4/29/24
• Elekta Instrument Recalls Disposable Biopsy Needle Kit for a Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle 4/26/24
• InfuTronix Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death 4/25/24
• Draeger Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power 4/25/24
• Outset Medical Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs 4/25/24
• Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA 4/25/24
• DeRoyal Industries Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist 4/24/24
• Fresenius Kabi Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death 4/17/24
• Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding 4/17/24
• Abbott/Thoratec Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction 4/14/24
• Medline Industries Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation and Sterile Water for Irrigation 4/8/24
• Honeywell Safety Products Issues Voluntary Recall of Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 used with the Fendall 2000 Eyewash Station 4/5/24
• Medos Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft 4/4/24
• Smiths Medical Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation 4/4/24
• Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage 4/3/24
• Quick Link to Medical Device Recalls

FDA News Release

• FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
• Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

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: Organ Care System (OCS) heart system

Manufacturer: Transmedics, Inc.
Brand: OCS Heart System
Model: Heart Organ Care System

Event: A donor heart was accepted for a hospital recipient. The transplant team used the Heart Organ Care System (OCS) to remove the donor’s heart (procurement). The heart procurement proceeded as normal; however, the team noted the compliance chamber of the OCS was getting larger than normal when they were priming the system. There was also a persistent air bubble that appeared next to the blood warmer. As a result, the heart could not be placed on the OCS and was rendered unusable for transplant due to the inability to flush preservation fluids through the heart while on the device. This event did not cause death nor serious injury to the potential recipient. The potential recipient remained on the heart transplant waitlist and was transplanted later with a different organ. However, this event resulted in an unusable heart that would have been used for transplant. The transplant team noted that there was a kink in the pulmonary artery (PA) tubing causing the above issues. The returned module was filled with water and cycled. The swollen compliance chamber and air bubble near the blood warmer were replicated. When the kink in the PA tubing line was fixed, the air bubble was able to pass, and the compliance chamber returned to a normal volume. Based on analysis, the direct root cause of the observed problems was from the kink in the PA tubing. The cause of the tubing kink is under investigation.

Type: Tubes, gastrointestinal (and accessories)

Manufacturer: Avanos Medical, Inc.
Brand: Cortrak 2 Enternal access device
UDI-DI: 00350770460536
Model: 46053
Lot: 30252001
Ref: 40-9551TRAK2

Event: The nurse was flushing medications through a Cortrak nasogastric feeding tube when he heard a popping sound. The fluid the nurse was flushing through tube exited the patient's mouth. After the tube was removed, staff saw a significant hole in the nasogastric tube.

Type: Catheter, intravascular occluding, temporary

Manufacturer: Balt USA LLC
Brand: Eclipse 2L
UDI-DI: 00818053022968
Model: ECL2L6x12
Lot: F230301054

Event: The patient underwent a procedure for a grade II arteriovenous malformation (AVM). Access through the groin and the procedure of the left frontal AVM was successful. Unfortunately, the microcatheter balloon stuck to the glued AVM. The device broke off as the surgeon was pulling back on the catheter to remove it. As seen on angiography, a piece of the catheter was kept in the renal artery to middle cerebral artery (MCA). The team thinks the catheter inside then caused a clot in the MCA, because previously, a clot had not developed there. The patient then had a procedure to remove blood clots from the arteries and veins (MCA thrombectomy), but the physician was unable to pull out the catheter inside. The patient had good reopening status of the previously blocked blood vessel after the thrombectomy procedure. A Heparin drip was started to lower the risk of stroke and multiple blood clots traveling from where it formed to other locations in the body. Within 10 hours, the patient showed neurological changes and a CT showed bleeding in the brain, so the Heparin was stopped. Days after the event, the patient’s worsening brain swelling and midline shift prompted an urgent removal of part of the skull to access and relieve pressure on the brain, and create space for  the brain, as well as placement of a drain in the space around the sac that has the spinal cord and nerves in it. Physicians are now considering a procedure to create an opening through the neck into the windpipe and placing a feeding tube into the stomach.

Type: Catheter, percutaneous

Manufacturer: Teleflex Inc.
Brand: Arrow
UDI-DI: 00801902001818
Model: IPN000134
Lot: 14F23L0168
Ref: CL-07611

Event: This patient had known, severe calcification in the legs (femoral arteries). On a recent catheterization, the sheath removal was complex. The interventional team appropriately elected to use the Arrow braided sheath to reinforce the stability and integrity of the access area. The team at the bedside was removing the femoral sheath (between the abdomen and thigh) when the sheath hub detached from the sheath’s shaft (located from the hip to the knee). The shaft remained in the patient and the patient began to lose blood. Pressure was applied. The patient briefly became unresponsive and was given one ampule of Epinephrine. Vascular surgery was  able to retrieve the sheath. Manual pressure was held for about 40 minutes. The patient was given two units of blood, started on Levophed, and transferred to the intensive care unit for close monitoring. The team removing the sheath is very experienced in sheath removal. We have not previously seen this situation, and believe it represents a sheath manufacturing mistake rather than user error or inappropriate use.

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. The 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: Oximeter

Manufacturer: Masimo Corp
Brand: RD Set Neopt-500 Spo2, PR, PI, PVI Neonatal Pulse Oximeter Non-adhesive; MasimoSET LNCS Neo Neonatal/Adult Pulse Oximeter Adhesive Sensor
UDI-DI: 10843997013267, 10843997000892 (x2), 10843997009659
Model: 4005, 4478 (x5), 2320 (x2), 4013
Lot: 22JTU, 22MFA x2, 23CRA, 24ALV, 23CCL, 23HKD, 22NTT
Ref: 4005, 4478 x5, 2320 x2, 4013

Event: This is a summary of multiple reports. This facility is having ongoing problems with the oxygen saturation probes in both the pediatric and adult patient populations. Staff have discovered oxygen probes with exposed wires after monitors indicated equipment malfunction. In some cases, staff found exposed and frayed wires on infants’ skin. Other times, the pulse oximeter flatlined or stopped reading on the monitor both while patients were resting and during procedures, including intubation (a tube that supports the airway so air can get to the lung).

Announcements

FDA Actions Provide Better Understanding of Mini-Slings for Female Stress Urinary Incontinence (SUI)

The FDA has taken several actions to better understand the safety and effectiveness of surgical mesh mini-slings to treat female SUI. The results continue to support the FDA’s conclusion that mini-slings have comparable clinical performance to traditional mid-urethral slings for treating female SUI. The FDA’s recommendations have not changed.

FDA Announced Home as a Health Care Hub Initiative to Help Advance Health Equity

The FDA announced a new initiative aimed to help reimagine the home environment as an integral part of the health care system. This new initiative, once established, will allow people to get the care they need, when they need it. The FDA is collaborating with patient groups, health care providers, the medical device industry, and housing experts to build the Home as a Health Care Hub and will keep the public informed as additional information becomes available.

FDA Meetings, Conferences and Workshops

• FDA Grand Rounds: Whole Genome Sequencing: A Powerful Scientific Tool that Delivered During the 2023 Pseudomonas Outbreak in Eye Drops 5/9/24
• How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases 5/9/24
• Final Rule: Medical Devices; Laboratory Developed Tests 5/14/24
• Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development 5/29/24 – 5/30/24

Links to FDA CDRH Databases and Other Information Sources

• Database of Registered Medical Devices and Manufacturers
• 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