BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000

    MDR report key: 16195310 · Received January 17, 2023

    Report

    Report Number
    MW5114358
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Report Date
    January 11, 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 COMMUNICATION. INBOUND CALL FROM PT IN REGARDS TO THE VOLUME OF HYQVIA. SPOKE WITH PT AND SHE STATED EVERY TIME SHE DRAWS THE MEDICATION SHE IS SHORT 10 TO 20 ML VOLUME (380 TO 390 INSTEAD FULL 400 ML VOLUME OF HYQVIA). I ASKED FOLLOW UP QUESTION AND FOUND OUT THAT SHE USED GRAVITY TO TRANSFER THE VOLUME FROM VIALS TO PULLING BAG. SHE REPLIED THAT AT THE END OF INFUSION, THE PUMP STARTED BEEPING LETTING HER KNOW THAT THE BAG IS EMPTY (NONE LEFT IN BAG). WHEN SHE READ THE TOTAL AMOUNT INFUSED ON PUMP, IT STATED 389 ML (FROM LAST INFUSION). I SAW WE PROGRAMMED THE PUMP FOR 410 ML AND MADE SURE WITH HER. PRODUCT FAULT OCCURRED WHILE IN USE WITH THE PATIENT. THIS RESULTED IN NO CLINICAL INJURY TO THE PT. REPLACING WITH NEW PUMP. MALFUNCTIONING PUMP WILL BE INVESTIGATED AND REPLACED. PT DIDN'T NEED BACKUP DEVICE AND WAS ABLE TO ADMINISTER INFUSION TO COMPLETION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95449 CURLIN 6000 PUMP, INFUSION FRN MOOG / ZEVEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female EXTENSION SET.| HYQVIA.