BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE, 3ML RG MEDICATION

    MDR report key: 13845985 · Received March 21, 2022

    Report

    Report Number
    MW5108355
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD
    Product Code
    MRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUTBOUND. PATIENT AND HUSBAND REPORT CADD MS3 PUMP ALARMING LOW VOLUME EARLIER THAN PROGRAMMED AND YESTERDAY, AFTER CONTINUING THE INFUSION AND RESTARTING PUMP, THE PUMP DISPLAYED ZERO. ACTUAL AMOUNT OF MEDICATION IN THE CARTRIDGE WAS 0.3 ML BUT THIS OCCURS WITH BOTH PUMPS. HUSBAND DESCRIBED THE CARTRIDGES AS HARD TO PULL THE PLUNGER AND HAS TO PUSH AND PULL SEVERAL TIMES TO TRY TO LUBRICATE THE BARREL. PUMP SN# (B)(4) NO CASSETTE LOT NUMBER PROVIDED. DID NOT NEED PUMP REPLACEMENTS. NO FURTHER DETAILS PROVIDED. WHELE LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134739 CARTRIDGE, 3ML RG MEDICATION ACCESSORIES, PUMP, INFUSION MRZ CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female PUMP