BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2970256 · Received February 12, 2013

    Report

    Report Number
    9610825-2013-00019
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Report Date
    January 14, 2013
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). (B)(4). THE PUMP HAS SOFTWARE VERSION 686G030102. THE VOLUMETRIC ACCURACY WAS TESTED 3 TIMES AT (B)(4) WITH NO ALARMS. FIRST TEST: (B)(4). SECOND TEST: (B)(4). THIRD TEST: (B)(4). THE PUMP OPERATED WITHIN SPECIFICATIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE BIOMED AT THE REPORTING FACILITY. THE BIOMED REP STATED THAT HE WAS NOT ABLE TO PROVIDE A RATE THAT THE PUMP WAS SET TO DELIVER AT THE TIME OF THE EVENT. HE DID STATE THAT THE PUMP WAS SET FOR AN INFUSION THAT WAS SOMEWHERE AROUND 15 MINUTES. HE ALSO CONFIRMED THAT NO ADVERSE REACTIONS WERE EXPERIENCED BY THE PT. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. PRIOR TO 10:37:26 AM ON (B)(6) 2013, NO INFUSION ACTIVITY OCCURRED. THE PUMP WAS SET AT A RATE AND VTBI (VOLUME TO BE INFUSED) OF 100 ML/HR AND 50 ML. AT 10:37:27 AM, INFUSION BEGAN AND AT 10:37:31 AM, A PRESSURE ALARM OCCURRED. AT 10:37:32 AM, INFUSION STOPPED WITH NO AMOUNT INFUSED. AT 10:37:34 AM, PRESSURE ALARM WAS TURNED OFF AND CONFIRMED. PER THE USER MANUAL, VOLUMETRIC ACCURACY OF (B)(4) IS ONLY GUARANTEED FOR INTERVALS OF (B)(4) AT A RATE OF (B)(4). AT 10:38:04 AM, INFUSION BEGAN AT THE SAME RATE AND AT 10:53:05 AM, THE INFUSION STOPPED WITH A COMPLETED VOLUME INFUSED OF 25.02 ML OR 100% OF EXPECTED DELIVERY. AT 10:53:23 AM, A NEW VTBI OF 60 ML AND RATE 240 ML/HR WAS SET. AT 10:53:30 AM, INFUSION BEGAN. AT 11:08:30 AM, INFUSION WAS COMPLETED AND PUMP WENT INTO KVO STATUS AND BEGAN INFUSING AT A RATE OF 3 ML/H WITH 60.01 ML INFUSED OF 100 % OF EXPECTED VOLUME. AT 11:09:05 AM, KVO WAS STOPPED WITH .02 ML INFUSED. PER THE USER MANUAL, VOLUMETRIC ACCURACY OF (B)(4) IS ONLY GUARANTEED FOR INTERVALS OF (B)(4) AT A RATE OF (B)(4). AT 11:14:21 AM, A NEW VTBI WAS SET FOR 40 ML. AT 11:14:22 AM, INFUSION BEGAN AT THE SAME RATE OF 240 ML/H AND AT 11:14:32 AM, INFUSION WAS STOPPED WITH .68 ML INFUSED OR 98% OF EXPECTED VOLUME AND THE PUMP WAS STOPPED FOR THE REST OF THE DAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED. NO CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE EVENT. 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

    (B)(4): UNDER INFUSION OF CALCIUM / MAGNESIUM; NO OTHER INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62118 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other