BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 2810193 · Received October 19, 2012

    Report

    Report Number
    9610825-2012-00207
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 19, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY (B)(4)): THE CUSTOMER REPORTED THAT THE PUMP INVOLVED IN ADVERSE INCIDENT PUMP INFUSION, NO ALARMS, BUT SYRINGE VOLUME NOT DROPPING. WHEN PUMP WAS PICKED UP, DRIVE HEAD HAD MOVED OUT OF PUMP WITHOUT PUMP BEING SWITCHED ON. DRIVE HEAD LOOSE. DETAILS OF INCIDENT: PT IS ON FENTANYL INFUSION. AS PT APPEARED TO BE BREATHING, ON TOP OF THE MANDATORY BREATHS ON THE VENTILATE SEDATION (INCLUDING FENTANYL) WAS BOLUSED AT 11.00. WHEN DOING OBSERVATIONS, I NOTICED THAT THE VOLUME IN THE SYRINGE DID NOT CORRELATE WITH THE AMOUNT I HAD BOLUSED. I ATTEMPTED TO BOLUS 2 MLS OF FENTANYL AND OBSERVED THAT THE SYRINGE VOLUME DID NOT CHANGE. AS THE BOLUSING OF FENTANYL HAD BEEN HAVING NO EFFECT ON THE PT, I HAD TO BOLUS MIDAZOLAM AND ADJUST THE VENTILATOR SETTINGS. AT NO POINT DID AN ERROR MESSAGE APPEAR ON THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other