BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC - IFVB

    MDR report key: 3173562 · Received June 5, 2013

    Report

    Report Number
    9610825-2013-00158
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B BRAUN (B)(4)N (THE MFR) AND (B)(4) (THE IMP). (B)(4). THE PUMP WAS TESTED THREE TIMES FOR VOLUMETRIC ACCURACY WITH A RATE OF 125ML/HR AND 25ML FOR 12 MINUTES: 1ST TEST: 25.7ML OR 102% OF EXPECTED VOLUME; 2ND TEST: 25.7ML OR 102% OF EXPECTED VOLUME; 3RD TEST: 25.8ML OR 103% OF EXPECTED VOLUME. THE PUMP PERFORMED WITHIN SPECIFICATION. MULTIPLE ATTEMPTS TO CONTACT THE REPORTING FACILITY TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. SINCE NEITHER THE DATE OF THE OCCURRENCE DAY NOR THE RATE/INFUSION PARAMETERS WAS PROVIDED BY THE CUSTOMER, THE DAY PRIOR TO THE DAY THE COMPLAINT WAS REPORTED WAS REVIEWED. THAT DAY, PER THE LOG, WAS (B)(6) 2013; THE DAY THE CUSTOMER INITIATED THE COMPLAINT WAS (B)(6) 2013. THERE WAS NO ACTIVITY FROM (B)(6) 2013. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. ON (B)(6) 2013 AT 14:43:29 THE PUMP WAS TURNED ON. AT 14:44:36 THE INFUSION WAS STARTED AT THE RATE OF 250ML/H. THE INFUSION WAS STOPPED AT 15:16:36 DUE TO PRESSURE ALARM AND 215.4ML OR 100% OF EXPECTED VOLUME INFUSED. AT 15:44:46 THE INFUSION WAS RESTARTED AT THE SAME RATE OF 250ML/H. THE INFUSION WAS STOPPED AT THE SAME TIME AT 15:44:50 DUE TO PRESSURE ALARM WAS ON, 0.2ML INFUSED. PER THE PROCEDURAL INSTRUCTIONS FOR INSPECTION (SERVICE MANUAL) RATE TEST ACCURACY OF -2.5/+7.5% IS ONLY GUARANTEED FOR INTERVALS OF >12MIN AT A RATE OF 125.0ML/H. AT 15:44:53 THE INFUSION WAS RESTARTED AT THE SAME RATE OF 250ML/H. THE INFUSION WENT ON AND AUTOMATIC TURN OVER KVO AT 15:53:06, 34.4ML INFUSED OR 100% OF EXPECTED VOLUME. THE INFUSION THEN WAS STOPPED AT 15:53:24 WHEN THE KVO WAS DONE. THE PUMP WAS TURNED OFF AT 15:55:31 AND WAS NOT USED FOR THE REST OF THE DAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED. WITHOUT THE ACTUAL DATE OF EVENT AND/OR INFUSION PARAMETERS, FURTHER EVAL COULD NOT BE PERFORMED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249593 VISTA BASIC - IFVB INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1