BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 17134554 · Received June 15, 2023

    Report

    Report Number
    9610825-2023-00246
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    December 13, 2022
    Report Date
    November 8, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    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 MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE WAS NOT AVAILABLE. ONLY THE HISTORY DATA WAS SENT FOR INVESTIGATION. THE DEVICE HISTORY FILES WERE ANALYZED. ON THE DAY OF OCCURRENCE, A BD PLASTIPAK 50ML SYRINGE WAS INSERTED AND THE LINE WAS PURGED, ONE TIMES. THE INFUSION STARTED WITH A RATE OF 60ML/H. DIRECTLY AFTER START, A BOLUS OF 2,5ML WAS GIVEN. 7 MINUTES LATER THE INFUSION WAS STOPPED AND THE PUMP SET INTO STANDBY FOR A FEW SECONDS. THE INFUSION WAS STARTED AGAIN AND STOPPED A FEW SECONDS LATER. THE PUMP WAS OUT INTO STANDBY SEVERAL TIMES AND THE SYRINGE WAS EXTRACTED. A TOTAL OF 10,12ML WAS PUMPED. NO OTHER ABNORMALITIES WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE 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

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM: "OVERINFUSION." ACCORDING TO THE CUSTOMER: "MORPHINE INFUSION DRAWN UP 4.1MG IN 50ML 5% GLUCOSE, AND ROCURONIUM DRAWN UP NEAT (200MG IN 20ML), IN VIEW OF PATIENT REQUIRING SEDATION FOR SAFE TRANSFER BACK TO TERTIARY UNIT. POST INDUCTION WITH KETAMINE (1MG/KG) AND ROCURONIUM (1MG/KG) PATIENTS BLOOD PRESSURE DROPPED SLIGHTLY SO 10ML/KG 0.9% FLUID BOLUS WAS GIVEN. AFTER RECEIVING THE FLUID BOLUS WE COMMENCED THE MORPHINE AND ROCURONIUM INFUSION. THE PATIENT INITIALLY REQUIRED A 2.5ML BOLUS OF MORPHINE WHICH WAS GIVEN VIA THE PUMP DUE TO HER BECOMING LIGHT ON SEDATION FOLLOWING HER INDUCTION AND INCREASE IN HR. THE PATIENT BP HOWEVER OBSERVED TO BE LOW AGAIN 51/32 SO A REPEAT 10ML/KG FLUID BOLUS WAS GIVEN AT APPROX 08:30AM WITH GOOD EFFECT. SHORTLY AFTER THIS WAS PUSHED IN WE OBSERVED THAT THE MORPHINE SYRINGE HAD A VOLUME OF 36ML LEFT IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956053 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown