BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3012307300-2022-02949

    MDR report key: 13485097 · Received February 8, 2022

    Report

    Report Number
    3012307300-2022-02949
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    November 1, 2021
    Report Date
    February 8, 2022
    Manufacturer
    NULL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (1/2, REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING PUMP #1 FOR DISPOSABLE). PER (B)(6) MEDWATCH MW5106039 SPONTANEOUS CALL FROM PATIENT. PATIENT'S LEGACY PUMP GAVE AN "NO DISPOSABLE" ALERT. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NO. DID WE REPLACE THE DEVICE? YES. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING ? YES. HAS THIS INCIDENT HAPPENED WITHIN THE PAST 6 MONTHS? (NURSING QUESTION) DOES THE PT RECALL? NO. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. THE LOT NUMBER FOR THE DEFECTIVE CASSETTES IS 4163625. REPORTED TO ''(8)(6)'' BY PATIENT/ CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881428 FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown