BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8368317 · Received February 25, 2019

    Report

    Report Number
    2016493-2019-00220
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    December 31, 2018
    Report Date
    February 11, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED FROM CONCOMITANT MEDICAL PRODUCTS: 1000ML B BRAUN BAG REF E8000 NDC 0264-7800-09 LOT J8L811 EXP 03/21 0.9% SODIUM CHLORIDE INJECTION; 1000ML BAXTER BAG NDC 0338-0675-04 LOT C993402 EXP APR17 40MEQ POTASSIUM CHLORIDE THE CUSTOMER¿S REPORT THAT THE PUMP MODULE NOT ALARMING FOR AIR IN LINE WAS NOT CONFIRMED. THE PCU WAS NOT RETURNED FOR THE INVESTIGATION THEREFORE THE EVENT AND ERROR LOGS COULD NOT BE REVIEWED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN GOOD CONDITION. REVIEW OF THE PUMP MODULE SHOWED THE PUMP WAS CONFIGURED FOR AN AIR BOLUS LIMIT SET TO 250L WITH ACCUMULATED AIR ENABLED. THERE WERE NO ERRORS OR MALFUNCTIONS RECORDED IN THE ERROR LOG DURING THE EVENT. THE PUMP MODULE THEN ALARMED FOR AIL THREE TIMES BETWEEN 8:37 AM AND 9:09 AM, AFTER EACH ALARM THE DEVICE WAS RESTARTED SHORTLY AFTERWARDS. THEN FINALLY CHANNELED OFF AT 10:40AM WITH NO FURTHER ALARMS. FUNCTIONAL TESTING PERFORMED ON THE DEVICE OBSERVED NO IRREGULARITIES. THERE WERE NO ANOMALIES OBSERVED WITH THE ADMINISTRATION SET. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ALARM FOR AIR IN LINE ALTHOUGH AIR BUBBLES WERE SEEN IN THE LINE. INFUSING WAS 50ML OF CEFTRIAZONE PROGRAMMED TO INFUSE AT 100ML/HR FOR 30 MINUTES. THERE WAS NO HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ALARM FOR AIR IN LINE ALTHOUGH AIR BUBBLES WERE SEEN IN THE LINE. INFUSING WAS 50ML OF CEFTRIAZONE PROGRAMMED TO INFUSE AT 100ML/HR FOR 30 MINUTES. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158421 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR (2)2426-0007| PRI TUBING,8015, THERAPY DATE (B)(6) 2018