BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 20034755 · Received August 22, 2024

    Report

    Report Number
    9610825-2024-00668
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Report Date
    August 21, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION: 1. THE PATIENT COULD NOT BE EXTUBATED DUE TO EXCESS SEDATIVE EFFECTS OF MORPHINE. THE MORPHINE INFUSION WAS STOPPED AND THE PATIENT WAS VENTILATED OVERNIGHT. EXTUBATED THE FOLLOWING DAY 2. A LAPAROTOMY WAS BEING COMPLETED WITH A MORPHINE INFUSION TO SEDATE THE PATIENT. 3. PATIENT REMAINED INTUBATED POST OPERATIVELY BUT NO DELAY TO THE PROCEDURE (B)(6) 2024 12:20:10 CET LISA FOX (FOXLISGB) PHONE (B)(6). THE INCIDENT TOOK PLACE ON 1ST OF MARCH 2024 AT AROUND 3PM. THE CLINICIANS BELIEVE THE PUMP HAS OVER INFUSED THE PATIENT. THE GIVING SET WAS CHANGED BEFORE THE LAPAROTOMY TOOK PLACE AND BOLUSES OF MORPHINE HAD BEEN GIVEN VIA THE PUMP. WHEN THEY REVIEWED THE SYRINGE, 8MLS OF MORPHINE HAD GONE, WHICH WAS LARGER THAN EXPECTED. THEY BELIEVE THAT 5MLS HAD BEEN USED TO PURE AND FLUSH THE LINES AND 3MLS HAD BEEN ADMINISTERED TO THE PATIENT. THEY WERE UNABLE TO EXTUBATE THE PATIENT DUE TO EXCESS SEDATIVE EFFECTS OF MORPHINE. THE MORPHINE INFUSION WAS STOPPED AND THE PATIENT REMAINED INTUBATED POST OPERATIVELY AND WAS VENTILATED AND THEN EXTUBATED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25727 PERFUSOR® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown