BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17510570 · Received August 11, 2023

    Report

    Report Number
    2523676-2023-00427
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 25, 2023
    Report Date
    September 29, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964294679
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). THE SAMPLE WAS VISUALLY EVALUATED WITH NO DEFECT NOTED. THE SAMPLE WAS ATTACHED TO OBSERVE IF IT WOULD FIT INTO THE PUMP THE TUBING DID NOT NEED TO BE STRETCHED AND THERE WAS NO EVIDENCE OF INTERFERENCE BETWEEN THE TUBING COUPLERS AND THE PUMP HOUSING. IN AN ATTEMPT TO REPLICATE THE REPORTED DEFECT OF THE AIR-IN-LINE ALARM ON THE PUMP, THE SAMPLE WAS ATTACHED TO THE PUMP AND THEN TESTED BY RUNNING THERAPY WHILE STAGGERING THE RATE OF FLOW THROUGHOUT THE THERAPY. NO ALARMS OCCURRED DURING THE TESTING OF THE RETURNED SAMPLE. THE SAMPLE WAS ALSO LEAK TESTED PER TP-MD-2000528 WITH NO LEAKAGES OBSERVED. FUNCTIONAL TESTING ALSO INCLUDED READING THE MILLIVOLT READING OF THE AIR SENSOR OF THE PUMP WITH THE SET. THE RESULTS OF THE AIR SENSOR ARE MIN. 823MV MAX.846MV. BASED ON THE RESULTS OF THE SAMPLE EVALUATION, THE PRODUCT MET INTERNAL SPECIFICATIONS, AND NO DEFECTS WERE DETECTED THAT COULD CONTRIBUTE TO AIR-IN-LINE ALARMS.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: PUMP GIVING AIL ALARMS DURING CHEMOTHERAPY. TUBING WAS RESEATED SEVERAL TIMES WITH, BUT ALARMS PERSISTED. TUBING EVENTUALLY NEEDED TO BE RESTRUNG FROM PHARMACY TO COMPLETE THERAPY. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596359 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 04046964294679

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown