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December 2024

Volume 24, Issue 12

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.

Highlighted Recalls

• Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure 11/19/24
• Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements 11/19/24
• Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge 11/19/24
• Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel 11/15/24
• Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure 11/1/24
• Quick Link to Medical Device Recalls

Letters to Health Care Providers

• Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting System 11/15/24
• Update: Evaluation of Airborne Chemicals from Neonatal Incubators 11/8/24

Guidances

• Final: Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

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: Ventilator, continuous, facility use Manufacturer: Maquet Critical Care AB  Brand: Servo-U Model: Servo-U Event: A Biomedical Engineering team member noticed the side arm that holds a humidifier on the ventilator was cracked near the center hinge. The team checked all Getinge Servo-U ventilators and found that two ventilators had the same cracking at the metal arm or were beginning to show signs of cracking in the identical location. Another 43 ventilators showed scratches in the same location. The manufacturer was notified and has expedited replacement arms. They have not responded with a weight rating for the ventilator arm. Photo: Scratch present on the ventilator arm, the same location a crack was found.

Type: Catheter, intravascular, therapeutic, long term greater than 30 days

Manufacturer: Bard Access Systems
Brand: BD Bard PowerPICC Solo 4FR
Model: 3194355
Ref: 3194355

Event: The patient originally had a peripherally inserted central catheter (PICC) line placed for antibiotics to be given and was discharged from the hospital at that time. The patient was readmitted one month later, and it was noted the PICC site was swollen. Doctor orders were placed to remove the PICC line and send the tip for culture. During the removal, the nurse documented that there was no resistance or difficulty felt when removing the line. However, only a portion of the PICC line came out. The doctor was immediately notified, and a chest and arm X-ray was obtained along with an ultrasound of the arm to verify that the retained piece was still in the arm. The patient was taken to interventional radiology and the retained piece was removed. The device was shipped to the manufacturer for review.

Type: Pump, infusion

Manufacturer: B. Braun Medical Inc. 
Brand: Infusomat Space S 
UDI-DI: 04046964660887
Cat: 9713051U, 8713051U

Event: Patient was on multiple critical medications given through a catheter (IV pump). The IV pump alarmed low battery even though it was plugged into an emergency outlet and the charging light was lit. A backup pump was obtained and started. Approximately one hour later, the new IV pump alarmed low battery even though it was plugged in. Then, the pump abruptly shut off within one minute of alarming. The patient’s blood pressure dropped quickly and required rapid titrations once a new IV pump was set up.

Type: Set, administration, intravascular Manufacturer: Baxter Healthcare Corp Brand: Duo-Vent UDI-DI: 00085412676630 Model: 2R8404 Lot: DR24C22079 Ref: 2R8404 Event: The dark blue slide clamp key is on backwards and you must twist the tubing to use it. This makes it challenging to deliver chemotherapy through the catheter. Photo: The red circle and arrow indicate where the slide clamp key inserts into the pump.

Type: Set, administration, intravascular

Manufacturer: Baxter Healthcare Corp
Brand: Duo-Vent
UDI-DI: 0085412676630
Model: 2R8404
Ref: 2R8404

Event: A nurse was placing the catheter to deliver the chemotherapy agent Pemetrexed (Alimta) into the patient. When the blue key was removed from the pump, it sliced the tubing and chemotherapeutic agent spilled from the bag onto floor and the base of the pump.

Type: General surgery tray Manufacturer: DeRoyal Industries, Inc. Brand: DeRoyal Laparotomy Pack UDI-DI: 00749756364430 Model: 89-10558 Cat: 89-10558 Lot: 61045501 Event: An unknown substance on the syringe plunger was found when staff opened a sterile pack. The substance was identified prior to patient contact.

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: Laparoscope, general plastic surgery

Manufacturer: Covidien LP 
Brand: Step 
UDI-DI: 20884521090849 
Model: S110000

Event: A pediatric patient with acute appendicitis was taken to the operating room. While inserting the laparoscopic ports (openings for minimally invasive surgery), the short pneumoperitoneum needle (device used to help create space for the procedure) had been replaced with a substitution needle which is longer than the one that is normally used. The needle hit the patient’s inner abdomen and caused an intramural hematoma (internal bleeding) in the sigmoid colon, which required repair. The colon was inspected directly. There was no full thickness injury other than the intramural hematoma.

Announcements

• FDA Qualifies WOUND-Q Instrument as a New Medical Device Development Tool (MDDT)

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