BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 4815032 · Received June 1, 2015

    Report

    Report Number
    9610825-2015-00206
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    January 11, 2015
    Report Date
    May 22, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET FOR EVALUATION AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL PUMP INVOLVED WAS NOT RETURNED FOR EVALUATION. HOWEVER, IN A PHONE CALL FROM THE REPORTER, SHE CONFIRMED THAT THEY HAD SENT THE PUMP TO THEIR CONTRACTED SERVICE PROVIDER AND THAT THE PUMP WOULD NOT BE COMING BACK TO BBRAUN FOR EVALUATION. THE REPORTER STATED THAT THE PUMP OPERATED AS INTENDED AND THAT IT WAS "USER ERROR" ON THEIR PART. SHE ADDED THAT THEY HAD NOT MAINTAINED THE PUMP PROPERLY, "IGNORED THE ALARMS" AND "HAD NOT BEEN CHARGING THE BATTERY". WITHOUT THE ACTUAL PUMP, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND FURTHER EVALUATION WAS NOT POSSIBLE. IF THE PUMP AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH: "INFUSION PUMP MALFUNCTION RESULTED IN TPN NOT BEING INFUSED FOR SEVERAL HOURS WITHOUT THE PUMP ALARMING TO ALERT STAFF OF NON-INFUSION. PATIENT DID NOT EXPERIENCE HYPOGLYCEMIA." MW # 5040550.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351872 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1