BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET NERIA GUARD 60CM 9MM

    MDR report key: 21632828 · Received March 18, 2025

    Report

    Report Number
    MW5167749
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 14, 2025
    Report Date
    February 14, 2025
    Manufacturer
    INTRAPUMP INFUSION SYSTEMS / UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS CALL FROM PATIENT'S FATHER TO REPORT HE WAS DOING A CARTRIDGE CHANGE AND PRIMING THE LINE WHEN HE NOTICED LARGE AIR BUBBLES CLOSE TO THE CONNECTOR THE SIZE OF A PEN TIP. PATIENT'S FATHER LET THE LINE DRIP WHILE CONTINUING TO PRIME TO TRY AND GET THE BUBBLES OUT BUT WAS NOT ABLE TO. HE STATED THEY WERE IN THE CONNECTOR NEAR THE ENTRANCE OF THE LINE THAT GOES TO THE PATIENT'S ARM. ANOTHER CARTRIDGE CHANGE WAS PERFORMED WITH NEW TUBING AND PATIENT'S FATHER CALLED BACK SAYING HE HAD THE SAME ISSUE WITH LARGE BUBBLES IN THE TUBING. HE SAID HE HAS NEVER HAD LARGE AIR BUBBLES PRESENT BEFORE WITH THE CLEO TUBING AND BELIEVES THERE MAY BE A DEFECT WITH THE NERIA TUBING. PROVIDED LOT NUMBER OF 6000356. PT WAS INFUSING AND WAS ADVISED TO WATCH FOR OCCLUSION ALARM ON REMOTE TO MAKE SURE AIR BUBBLES WERE NOT OBSTRUCTING THE FLUID PATHWAY. PATIENT'S FATHER WILL USE A DIFFERENT LOT NUMBER OF TUBING FOR NEXT CARTRIDGE CHANGE. REF REPORT: MW5167750. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211745 INF SET NERIA GUARD 60CM 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA INTRAPUMP INFUSION SYSTEMS / UNOMEDICAL A/S 6000356

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male AMBRISENTAN| REMUNITY CART W/FILL AID| WINREVAIR SD (2/KIT)