BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 5106035 · Received September 25, 2015

    Report

    Report Number
    2016493-2015-00663
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 2, 2015
    Report Date
    September 5, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT THAT AN INFUSION EMPTIED EARLY COULD NOT BE CONFIRMED. THE REPORT FROM THE CUSTOMER THAT THE UPPER PLATEN HINGE POST WAS FOUND TO BE BROKEN WAS CONFIRMED FROM PICTURES RECEIVED FROM THE CUSTOMER AND DURING AN ON-SITE INSPECTION PERFORMED BY CAREFUSION. THE ASSOCIATED PCU AND THE CUSTOMER¿S DATA SET WERE NOT RETURNED FOR INVESTIGATION; THE LOGS WERE RECEIVED FROM THE CUSTOMER DURING AN ON-SITE INSPECTION. REVIEW OF THE LOG SHOWED AN INFUSION OF DRUG ID 133, 400 MICROGRAM/100 ML, WAS STARTED AT 4.14ML/HR ON (B)(6) 2015 AT 1:11PM, WITH A VTBI OF 80ML. THE INFUSION WAS STOPPED BY AN AIR IN LINE ALARM AT 2:03PM, WITH A VOLUME INFUSED RECORDED AS 3.371ML, WHICH SUGGESTS A REMAINING VTBI OF 76.629ML. THE INFUSION WAS THEN TERMINATED AT 2:16PM. ON-SITE INSPECTION OF THE PUMP MODULE NOTED THE UPPER PLATEN HINGE POST HAD BROKEN OFF. THE BROKEN PIECE WAS NOT FOUND. THE INSTRUMENT SEAL WAS BROKEN, AND MINOR IMPACT DENTS WERE NOTED IN THE DOOR AND REAR CASE. THE INSTRUMENT SEAL WAS BROKEN ON THE ASSOCIATED PCU AND DRIED FLUID RESIDUE WAS NOTED ON THE BODY OF THE IUI CONNECTORS. THE REAR CASE HAD CHIPS IN THE UPPER CORNERS OF THE REAR CASE. THE MAIN BATTERY WAS NOT AN APPROVED MODEL FOR THE ALARIS SYSTEM. NO TESTING WAS PERFORMED BY CAREFUSION. THE CUSTOMER REPORTED THEIR RATE ACCURACY TESTING USING ASM V 9.8 FOUND THE DEVICE TO BE INFUSING WITHIN SPECIFICATION, BUT FAILED A RETEST WHEN THE PLATEN ASSEMBLY WAS DISLODGED AT THE UPPER HINGE POST. THE CUSTOMER¿S RATE ACCURACY TEST SETUP WAS DETERMINED TO NOT BE THE RECOMMENDED TEST SETUP; THEIR TEST SET WAS EXPIRED AND HAD BEEN CUT AT THE DISTAL END WITH A 2 GANGED VALVE CONNECTED FOR USE AS A BOTH A RATE ACCURACY TESTER AND AN OCCLUSION PRESSURE TESTER. NO FURTHER TESTING WAS PERFORMED BY CAREFUSION DUE AN APPROVED RATE TEST SET NOT BEING AVAILABLE. THE PROXIMATE CAUSE FOR THE CUSTOMER¿S REPORT IS ATTRIBUTED TO THE BROKEN UPPER PLATEN HINGE POST. THE ROOT CAUSE FOR THE UPPER PLATEN HINGE POST BREAKAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636682 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other