BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 3001256 · Received March 1, 2013

    Report

    Report Number
    9610825-2013-00041
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 1, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (B)(4). THE VOLUMETRICS WAS TESTED THREE TIMES AT 510.9ML/HR FOR 1 HOUR 0 MINUTES WITH NO FREE FLOW IN STANDBY, DOOR CLOSE OR OPENED: 1ST TEST: 515ML OR 101% OF EXPECTED VOLUME IN 1 HOUR AND 0 MINUTES; 2ND TEST: 517ML OR 101% OF EXPECTED VOLUME IN 1 HOUR AND 0 MINUTES; 3RD TEST: 518ML OR 101% OF EXPECTED VOLUME IN 1 HOUR AND 0 MINUTES. THE TEST RESULTS ARE WITHIN SPECIFICATIONS. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. ON (B)(6) 2013 AT 12:48:56 THE PUMP WAS READY FOR INFUSION; A NEW RATE WAS SET TO 100ML/H AND VTBI (VOLUME TO BE INFUSED) OF 100ML. THE INFUSION WAS STARTED AT 12:51:12. AT 12:51:20 A PRESSURE ALARM OCCURRED AND THE INFUSION STOPPED WITH 0.01ML 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 12:51:27 THE PRESSURE ALARM WAS CONFIRMED AND AT 12:51:29 THE INFUSION WAS RESTARTED. AT 13:38:57 AN UPSTREAM ALARM OCCURRED AND THE INFUSION WAS STOPPED WITH 79.09ML INFUSED OF 100% OF EXPECTED VOLUME. THE UPSTREAM ALARM WAS CONFIRMED AT 13:41:49. THE PUMP THEN WENT INTO STANDBY MODE AT 13:41:49 AND REMAINED NOT BEING RUN UNTIL 15:28:28. AT 15:28:52 A NEW RATE WAS SET AT 510.9ML/H THEN THE PUMP WAS PUT ON STANDBY FOR 4 MINUTES. AT 15:32:35 THE PUMP WAS STARTED AT 15:32:37 A PRESSURE ALARM OCCURRED. THE INFUSION WAS STOPPED AT 15:32:38 WITH 0.01ML 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 15:32:40 THE PRESSURE ALARM WAS CONFIRMED. AT 15:32:42 THE PUMP WAS RESTARTED AT THE PREVIOUS RATE OF 510.9ML/HR. AT 15:43:30 AN UPSTREAM ALARM OCCURRED AND THE INFUSION WAS STOPPED WITH 91.9ML INFUSED OR 100% EXPECTED VOLUME. AT 15:43:32 THE UPSTREAM ALARM WAS CONFIRMED AND 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: # 8713060U; SERIAL # (B)(4); OVER INFUSION: PUMP SET TO DELIVER VOLUME OF 510.9 OVER ONE HOUR. VOLUME OF 579.19 DELIVERED IN FIVE MINUTES AS PER NURSING. DRUG/SOLUTION UNKNOWN. PATIENT REQUIRED EXTENDED MONITORING, NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88864 INFUSOMAT SPACE INFUSOMAT SPACE ACM-KIT FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other