BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 19606005 · Received June 25, 2024

    Report

    Report Number
    2523676-2024-00639
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 30, 2024
    Report Date
    July 31, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964188558
    PMA / PMN Number
    K173361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE PHOTOGRAPH OF THE INFUSION PUMP SCREEN WAS SUBMITTED FOR EVALUATION. THE PHOTOGRAPH WAS EVALUATED, AND A PROPER EVALUATION COULD NOT BE PERFORMED FROM THE EVIDENCE PROVIDED. THE REPORTED DEFECT WAS NOT CONFIRMED. ALL AVAILABLE INFORMATION WAS FORWARDED TO THE SUPPLIER FOR FURTHER EVALUATION. A POSSIBLE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: ZOSYN IVPB FREE-FLOW CONCERNS AT (B)(6) HOSPITAL. DETAILED INQUIRY DESCRIPTION: RECEIVED THE FOLLOWING EMAIL FROM (B)(6) ON 5/29/2024. "THERE WAS AN INCIDENT WITH BRAUN PUMP INFUSING ZOSYN LAST NIGHT ON 1 W AN INCIDENT REPORT WAS PLACED. DATE (B)(6) 2024 TIME 5:21 AM: RN STATES BRAUN INTEGRATION USED WAS IN THE ROOM WITH PT AND IVPB INFUSED FREELY. THIS IS DOCUMENTED ON INFUSION VERIFIER ON SCREEN SHOT RN ALSO STATED AFTER THIS OCCURRED THE PUMP STILL SAID ZOSYN HAD OVER 3 HOURS REMAINING TO INFUSE ON BRAUN PUMP LANDING SCREEN WHICH I ALSO SAW ON THE PUMP. THE PUMP AND TUBING IS NOW IN BIO MED: BME # S001182 BAR CODE 807421. LOT # PIGGY BACK TUBING 0061934189." CUSTOMER ISOLATED PUMP AND TUBING SAMPLES IN BIOMED. EPIC EHR SCREENSHOT (ATTACHED) DISPLAYS 0.99 ML VOLUME INFUSED BY PUMP FROM 05:21 TO 05:26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448086 IV ADMINISTRATION SET SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061934189 04046964188558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown