BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY PUMP

    MDR report key: 14632285 · Received June 7, 2022

    Report

    Report Number
    MW5110169
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 31, 2022
    Report Date
    May 31, 2022
    Manufacturer
    UNK
    Product Code
    QJY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS, REMUNITY REMOTE HAS OCCLUSION ALARM. SECOND TIME IN LAST 2 DAYS. NO KINKS IN TUBING. LAST TIME, PATIENT CHANGED CASSETTE AND RESUMED INFUSING. LAST CHANGED INFUSION SITE 2 DAYS AGO. RECOMMENDED CHANGING SITE DUE TO TIMING. CALLED CNSS (B)(6), AND DID 3 WAY CALL. PATIENT HAS TROUBLE BREATHING NOW, OXYGEN SATURATION LOWER THAN NORMAL. CNSS RECOMMENDED USING OXYGEN AND CHANGING INFUSION SITE AS WELL. PATIENT TO CALL CNSS BACK DIRECTLY AFTER CHANGE. TUBING AND PRODUCT LOT NUMBER AND EXPIRATION DATES UNKNOWN. NO FURTHER INFORMATION PROVIDED. DOSE OR AMOUNT: 39.76 NG/KG/MIN. RETURN TRACKING INFORMATION NOT AVAILABLE. PHOTOGRAPHS WERE NOT INCLUDED. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF PUMP UNKNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? YES; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NO; DID WE [MFR] REPLACE THE DEVICE? NO; DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323727 REMUNITY PUMP INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY UNK NA UNK
    323728 CASSETTE SET, I.V. FLUID TRANSFER QJY UNK
    323729 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR QJY SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female