BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE SETS

    MDR report key: 9917138 · Received April 2, 2020

    Report

    Report Number
    9616066-2020-01236
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    February 1, 2020
    Report Date
    March 16, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403235238
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE PRESSURE DISC ON THE TUBING HAD A CRACK/CUT (SLICE) AND FLUID LEAKED WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OF THE SET NOTED A SLICE DAMAGE ON THE PRESSURE SENSING DISC FILM¿S MEMBRANE. NO DAMAGES WERE OBSERVED ON THE PRODUCT PACKAGING POUCH AND NO OTHER ANOMALIES WERE OBSERVED. FUNCTIONAL TESTING CONFIRMED SMALL DROPLETS LEAKING FROM THE DAMAGE OF THE PRESSURE DISC¿S FILM MEMBRANE. THE ROOT CAUSE OF THE SLICE DAMAGE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD FOR MODEL 30916-07 WITH LOT NUMBER 19115555 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS WERE BUILT IN 1 LOT ON 06NOV2019. THE SEARCH SHOWED THAT THERE WERE NO QUALITY NOTIFICATIONS FOR THE FAILURE MODE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿INSULIN HOOKED UP TO PRESSURE SENSITIVE DISC TUBING. ALL INSULIN ENDED UP ON FLOOR BECAUSE PRESSURE DISC ON TUBING HAD CRACK/CUT ON DISC AND FLUID LEAKED OUT WHEN PRIMING THE LINE. NO HARM TO PATIENT OTHER THAN DELAY OF TREATMENT."

    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

    RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿INSULIN HOOKED UP TO PRESSURE SENSITIVE DISC TUBING. ALL INSULIN ENDED UP ON FLOOR BECAUSE PRESSURE DISC ON TUBING HAD CRACK/CUT ON DISC AND FLUID LEAKED OUT WHEN PRIMING THE LINE. NO HARM TO PATIENT OTHER THAN DELAY OF TREATMENT." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2020 WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382015 ALARIS SYRINGE MODULE SETS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 30916-07 19115555 10885403235238

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA BD 10ML SYRINGE, THERAPY DATE UNK| THERAPY DATE 02/01/2020