BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11335313 · Received February 16, 2021

    Report

    Report Number
    2016493-2021-26125
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    December 14, 2020
    Report Date
    December 16, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). INVESTIGATION CONCLUSION: THE COMPLAINT OF OVER INFUSION WAS NOT CONFIRMED IN THE LOGS OR REPRODUCED DURING TESTING. THE INCIDENTAL FINDING OF CHANNEL DISCONNECT CAN BE ATTRIBUTED TO THE USER PHYSICALLY REMOVING THE DEVICE FROM THE SYSTEM BEFORE STOPPING THE INFUSION. THE DATASET WAS NOT PROVIDED SO SOME MEDICATIONS COULD NOT BE CONFIRMED. REVIEW OF THE PCU ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. REVIEW OF THE PCU EVENT LOG SHOWED, ON (B)(6) 2020 AT 3:06 AM, THE SUSPECT DEVICE RECEIVED A REMOTE IV FOR AN UNCONFIRMED MEDICATION (DRUGID=360) TO INFUSE WITH A DOSE OF 10.7 UNITS/KG/HR (25000 UNIT/250 ML) AND A CALCULATED RATE OF 9.9938 ML/HR (VTBI= 250 ML). AT 3:20 AM, THE SUSPECT DEVICE ALARMED FOR AIR IN LINE. THE SUSPECT DEVICE WAS RESTARTED AND PAUSED TWO (2) TIMES BEFORE THE DEVICE WAS CHANNELED OFF AT 3:28 AM. TOTAL VOLUME INFUSED= 2.42 ML. OVER INFUSION TESTING WAS PERFORMED USING THE CUSTOMER¿S SOURCE PUMP MODULE S/N 14278079 AND RETURNED PCU S/N (B)(4). RESULTS INDICATE THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. FUNCTIONAL TESTING ON THE RETURNED ADMINISTRATION SHOWED NO ANOMALIES. TESTING SHOWED THE DEVICE WAS DELIVERING FLUID WITHIN SPECIFICATION. TESTING OF THE SYSTEM¿S IUI¿S SHOWED NO ERRORS OCCURRED DURING AMBULATION. CONCENTRICITY TESTING OF THE RETURNED ADMINISTRATION SET SHOWED THE SET WAS WITHIN SPECIFICATION. DEVICE INSPECTION: THE PCU S/N (B)(4) WAS RECEIVED IN FAIR CONDITION. THE INSTRUMENT SEAL WAS REMOVED. DRIED FLUID AND CORROSION WERE OBSERVED ON THE FEMALE IUI. DRIED FLUID WAS OBSERVED ON THE MALE IUI. IMPACT MARK ON THE FRONT LEFT EDGE FROM A PREVIOUSLY MATED DEVICE¿S BACKED OUT PIVOT LATCH SCREW. DRIED FLUID INGRESS OBSERVED ON THE REAR CASE UNDER BOTH IUIS. MALE IUI OBSERVED WITH DAMAGE TO PLASTIC ISOLATION RIBS. KEYPAD OBSERVED CRACKED ON THE BOTTOM. BATTERY CRACKED AT THE SCREW HOLES. BATTERY MISSING ONE RUBBER FOOT. THE RETURNED USED ADMINISTRATION SET (MODEL: 11171447) WAS RECEIVED IN GOOD CONDITION. THE RETURNED ADMINISTRATION SET WAS VISUALLY INSPECTED FOR INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF AN OVER INFUSION WAS NOT IDENTIFIED. THE PROBABLE CAUSE OF THE CHANNEL DISCONNECT CAN BE ATTRIBUTED TO THE USER PHYSICALLY REMOVING THE DEVICE FROM THE SYSTEM BEFORE STOPPING THE INFUSION. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 10DEC2014. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR PCU S/N 14250546 WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE SOURCE DEVICE PCU S/N (B)(4) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEPARIN DRIP WAS INITIATED AS ORDERED. FOR 10.7 UNITS/KG/ HOUR. WITHIN 30 MINUTES THE ALARIS PUMP BEEPING VOLUME TO BE INFUSED. HEPARIN BAG COMPLETELY EMPTY. FLOOR WAS NOT WET AS YOU WOULD ANTICIPATE IF A HOLE WERE IN THE TUBING OR BAG. INFUSION IMMEDIATELY STOPPED, MEDICAL DOCTOR WAS NOTIFIED, LABS OBTAINED. PTT UNDETECTABLE, PTT REDRAWN WITH SAME RESULTS AS UNDETECTABLE COAGULOPATHY. ALARIS PUMP, CHANNEL AND MEDICATION IMMEDIATELY REMOVED FROM PATIENT¿S ROOM, BAGGED AND MARKED AS FAULTY FOR FURTHER INVESTIGATION. CONTINUED FREQUENT LAB MONITORING NECESSARY. NO REVERSAL AGENTS GIVEN. NO OBVIOUS OUTWARD SIGNS OF BLEEDING NOTED. THERE WAS NO RISK OR CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228348 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR