BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000 PUMP CMS

    MDR report key: 16305567 · Received February 3, 2023

    Report

    Report Number
    MW5114714
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 24, 2023
    Report Date
    January 24, 2023
    Manufacturer
    MOOG/ZEVEK, INC.
    Product Code
    FRN
    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 (B)(6), HOME HEALTH NURSE REGARDING GAMMAGARD INFUSION. PATIENT RECEIVED TODAY. PER RN, SHE STOPPED THE INFUSION WITH ABOUT 30 MIN REMAINING SINCE PT WAS HAVING MUSCLE TENSION/"FEELING LIKE HE WAS ABOUT TO SHIVER"/ TENSING UP. RN GAVE PT WARM TEA AND WAITED ABOUT 45 MINS. BEFORE TRYING TO RESTART INFUSION. WHEN RN TRIED TO RESTART THE PUMP, THE START BUTTON WOULD NOT WORK. RN STATES ALL OTHER BUTTONS WORKED BUT THE START BUTTON. RN STATES SHE TRIED REMOVING BATTERIES AND PUTTING BACK IN AND RESTARTING BUT DID NOT WORK. RN REPORTS PT HAD ABOUT 20ML REMAINING OF INFUSION. RN WENT TO INFUSE REMAINDER VIA GRAVITY SINCE PUMP WAS NOT WORKING AND PT REPORTED HE DID NOT WANT THE REMAINDER OF THE INFUSION. NEW PUMP BEING SENT TO PT. CALLED MD TO ADV THAT PT DID NOT RECEIVE FULL DOSE. UNKNOWN IF PT HAD ANY SIDE EFFECT FROM NOT RECEIVING FULL DOSE. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114556 CURLIN 6000 PUMP CMS PUMP, INFUSION FRN MOOG/ZEVEK, INC. 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male GAMMAGARD.