BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4819870 · Received June 4, 2015

    Report

    Report Number
    2016493-2015-00415
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE LOGS BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF AN OVER INFUSION OF SODIUM ACETATE WITH HEPARIN WAS CONFIRMED. LOG ANALYSIS RESULTS: PUMP MODULE SN, (B)(4) WAS DETERMINED TO BE INFUSING SODIUM ACETATE WITH HEPARIN ON THE DAY OF THE REPORTED EVENT. THE CUSTOMER PROFILE WAS DETERMINED TO BE NEONATAL. ON (B)(6) 2015 AT 10:57AM THE PCU (SN (B)(4)) WAS POWERED ON AND THE SOURCE PUMP MODULE DEVICE WAS ATTACHED AS CHANNEL B SECONDS LATER. AT 5:34PM THE SOURCE PUMP MODULE WAS PROGRAMMED USING GUARDRAILS FLUIDS FOR SODACET 34MEQ/L +HEP (SODIUM ACETATE WITH HEPARIN) AS DRUG ID=159. THE USER ENTERED A RATE OF 0.5ML/HR WITH A VTBI OF 10ML AND STARTED THE INFUSION. AT 10:38PM THE USER CHANGED THE RATE TO 1ML/HR AND STARTED THE INFUSION. AT 11:39PM THE USER CHANGED THE RATE TO 0.5ML/HR AND STARTED THE INFUSION. AT 11:40PM THE USER PAUSED THE PUMP MODULE DEVICE. AT 11:44PM THE USER RESTARTED THE PUMP MODULE. ON (B)(6) 2015 AT 12:40AM THE USER PAUSED THE PUMP MODULE DEVICE. AT 12:45AM THE PUMP MODULE WAS POWERED OFF, THE PRIMARY VOLUME INFUSED WAS RECORDED AS 4.018ML INSPECTION OF THE SOURCE DEVICE WAS PERFORMED BY (B)(6), MANAGER OF TECHNICAL CUSTOMER ADVOCACY, DURING AN ON-SITE VISIT AT (B)(6) MEDICAL CENTER ((B)(6) 2015). INSPECTION CONFIRMED THAT THE DEVICE HAD A NON-CAREFUSION MEMBRANE FRAME INSTALLED. TESTING ALSO FOUND THAT WHEN THE MEMBRANE WAS REPLACED WITH A CAREFUSION PART, NO UNREGULATED FLOW CONDITION WAS PRESENT. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF AN OVER INFUSION OF SODIUM ACETATE WITH HEPARIN WAS DETERMINED TO BE DUE TO THE USE OF A 3RD PARTY MEMBRANE FRAME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A .2% NA ACETATE WITH 50U HEPARIN OVER INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361759 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 8015, 8100, PRI TUBING