BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3001274 · Received March 1, 2013

    Report

    Report Number
    9610825-2013-00039
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). (B)(4). THE ACTUAL PUMP INVOLVED IN THE EVENT WAS RETURNED FOR EVALUATION THE PUMP HAS SOFTWARE VERSION 686G030103. THE PUMP WAS TESTED FOR VOLUMETRICS THREE TIMES WITH 250ML/H AND 25ML FOR 6 MINUTES 0 SECONDS WITH NO FREE FLOW, DOOR CLOSE OR OPENED: 1ST TEST: 24.8ML OR 99% OF EXPECTED VOLUME FOR 6 MINUTES 0 SECONDS; 2ND TEST: 24.9ML OR 99% OF EXPECTED VOLUME FOR 6 MINUTES 0 SECONDS; 3RD TEST: 24.9ML OR 99% OF EXPECTED VOLUME FOR 6 MINUTES 0 SECONDS. THE TEST RESULTS ARE WITHIN SPECIFICATION. IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER STATED THAT HE WAS UNABLE TO PROVIDE ANY MORE INFORMATION ON THE EVENT. HE PROVIDED THE RISK MANAGER'S CONTACT NUMBER FOR FURTHER INFORMATION. MULTIPLE ATTEMPTS MADE TO THE RISK MANAGER HAVE NOT BEEN SUCCESSFUL. THE PUMP'S OPERATIONAL LOG WAS REVIEWED FOR THE LAST KNOWN INFUSION. ON (B)(6) 2012, AT 5:27:30PM THE PIGGYBACK, SECONDARY INFUSION WAS SELECTED WITH A NEW VTBI OF 100ML AT A RATE OF 100ML/HR. THE INFUSION WAS STARTED AT 5:27:35PM AND THE INFUSION WAS STOPPED AT 5:27:41PM WITH 0.17ML INFUSED. INFUSED VOLUME CANNOT BE ACCURATELY CALCULATED, PER THE USER MANUAL VOLUMETRICS ACCURACY OF (B)(4) IS ONLY GUARANTEED FOR INTERVALS OF >2MIN. AT A RATE OF 25.0ML/H). AT 5:27:46PM THE PUMP WAS RESTARTED AT A NEW RATE OF 400ML/H. AT 5:42:44PM THE PIGGYBACK COMPLETED WITH 99.8ML INFUSED OR 100% OF THE EXPECTED VOLUME. THE AUTOMATIC TURN OVER TO PRIMARY INFUSION OCCURRED. THE PRIMARY INFUSION WAS SET TO 100ML/H AT 11:01:32AM ON (B)(6) 2012. AT 8:36:29PM AN AIR BUBBLE ALARM OCCURRED AND THE INFUSION WAS STOPPED WITH 289ML INFUSED OR 100% OF EXPECTED VOLUME. THE AIR IN LINE ALARM WAS CONFIRMED AT 8:37:09PM AND THE PUMP WAS PLACED INTO STANDBY MODE. THE PUMP WAS NOT USED FOR THE REST OF THE DAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MFR. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4). REPORTS OVER INFUSION; NURSE NOTED IV FREE FLOWING ON MAINTENANCE I.V. WHEN PUMP ALARMED AIR IN LINE, FOUND BAG ALMOST EMPTY. PUMP REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88866 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other