BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY DEKA PUMP

    MDR report key: 13386158 · Received January 27, 2022

    Report

    Report Number
    MW5107052
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 17, 2022
    Report Date
    January 18, 2022
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    QJY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SOLICITED CALL TRANSFERRED BY (B)(6) FROM PATIENT STATING THAT ONE OF HER REMUNITY PUMP/REMOTE COMBINATIONS IS VERY SLOW TO CONNECT AND SHOWED 40 HOURS INSTEAD OF 70 HRS. REMOTE# SN (B)(4), PUMP SN# N/A, CURRENTLY BECAUSE IT IS IN USE, PT STATES SHE WILL CALL BACK IN A COUPLE DAYS TO PROVIDE PUMP SERIAL NUMBER WHEN SHE DOES HER NEXT CHANGE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? NO DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE REPLACE DEVICE? YES; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844760 REMUNITY DEKA PUMP INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP. REMUNITY DEKA PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female