BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9672312 · Received February 5, 2020

    Report

    Report Number
    9616066-2020-00383
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 17, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: D10. THE CUSTOMER¿S REPORT THAT THAT THE TUBING BALLOONED ALONG THE SILICONE PUMP SEGMENT DURING PRIMING WAS CONFIRMED. THE BALLOON (SET 1) WAS LOCATED BELOW THE UPPER FITMENT¿S OUTLET PORT OF THE PUMP SEGMENT. FURTHER VISUAL INSPECTION OF SET 1 UNDER MAGNIFICATION FOUND THE WALLS OF THE SILICONE TUBING SEGMENT TO BE CONCENTRIC. FUNCTIONAL AND PRESSURE TESTING FOUND NO ANOMALIES WITH THE ASSOCIATED EIGHT NEW SETS. THE SETS WERE VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING, OR DAMAGE TO THE COMPONENTS. FUNCTIONAL TESTING WAS PERFORMED BY SPIKING SET 1 TO A LAB IV BAG FILLED WITH BLUE DYE WATER AND REPRIMING THE SET VIA GRAVITY. THE SILICONE TUBING SEGMENT OF SET 1 WAS CUT AND INSPECTED UNDER MAGNIFICATION; THE WALLS WERE FOUND TO BE CONCENTRIC. PREVIOUSLY INVESTIGATED COMPLAINTS FOR THIS SAME FAILURE MODE DETERMINED THAT THE BALLOONING IS CAUSED BY EXCESS PRESSURE WITHIN THE SILICONE TUBING SEGMENT. THE ROOT CAUSE FOR THE SOURCE OF THE EXCESSIVE PRESSURE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING BALLOONED ALONG THE SILICON PUMP TUBING SEGMENT DURING PRIME.A LTHOUGH REQUESTED, THERE HAS BEEN NO ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING "BALLOONED", ALONG THE SILICONE PUMP TUBING SEGMENT DURING PRIMING. ALTHOUGH REQUESTED, THERE HAS BEEN NO ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING BALLOONED ALONG THE SILICON PUMP TUBING SEGMENT DURING PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137244 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION 2420-0007 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1