BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMTY WNTY RPLMT PUMP KIT

    MDR report key: 12481294 · Received September 15, 2021

    Report

    Report Number
    MW5103999
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 28, 2021
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    QJY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED ONE OF HER PUMPS DIDN'T ALARM THAT IT HAD LOW VOLUME BEFORE IT RAN OUT. PATIENT DOES NOT NEED REPLACEMENT AS SHE HAS TWO FUNCTIONAL PUMPS AT THIS TIME. PATIENT COULD NOT PROVIDE SERIAL NUMBER AT TIME OF CALL AS SHE WAS NOT AT HOME. ISSUE OCCURRED SOMETIME LAST WEEK. PRODUCT FAULT OCCURRED WHILE IN USE. PRODUCT INJURY DID NOT CAUSE INJURY. DEVICE AVAILABLE FOR INVESTIGATION. DEVICE DID NOT NEED REPLACED AS PATIENT HAS TWO FUNCTIONAL DEVICES. INFUSION IS LIFE SUSTAINING. NO OTHER INFO AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375557 REMTY WNTY RPLMT PUMP KIT INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR