BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8345684 · Received February 15, 2019

    Report

    Report Number
    9616066-2019-00434
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 30, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403232602
    PMA / PMN Number
    K934095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE TUBING CRACKED AND BROKE OFF WAS CONFIRMED. VISUAL INSPECTION OF THE SET FOUND A BREAK OCCURRING BETWEEN THE VENTED SPIKE AND THE UPPER FITMENT. FURTHER VISUAL INSPECTION UNDER MAGNIFICATION OF THE BROKEN VENTED SPIKE AND UPPER FITMENT OBSERVED STRESS MARKINGS ON BOTH SURFACES WHICH MATCHED UP BETWEEN BOTH SURFACES WHEN PLACED TOGETHER. THE BREAK WAS OBSERVED TO BE JAGGED AND NOT A CLEAN BREAK. THE CAUSE OF THE CUSTOMER'S REPORT IS A BREAK BETWEEN THE SPIKE ADAPTOR AND UPPER FITMENT. THE ROOT CAUSE OF THE BREAK WAS EXCESSIVE FORCE AS INDICATED BY THE STRESS MARKS AND JAGGED BREAK AT THE BREAK SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE TUBING CRACKED AND BROKE OFF WHEN TAPPED OR NUDGED. THE TUBING WAS PRIMED WITH NS AND CONNECTED TO THEY SITE OF THE PRIMARY TUBING AT THE PORT CLOSEST TO THE PATIENT. THERE WAS NO HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: NEEDLE INTROCAN SAFETY 20G 1.1X32MM;10ML EXCELSIOR MEDICAL SYRINGE LOT 3134025 EXP 2020-08-01 0.9% SODIUM CHLORIDE INJECTION ZR FLUSH; THERAPY DATE (B)(6) 2019. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. ALTHOUGH REQUESTED, PATIENT DEMOGRAPHICS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBING CRACKED AND BROKE OFF WHEN TAPPED OR NUDGED. THE TUBING WAS PRIMED WITH NS AND CONNECTED TO THE Y SITE OF THE PRIMARY TUBING AT THE PORT CLOSEST TO THE PATIENT. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136684 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10010483 10885403232602

    Patients

    Seq Age Sex Outcome Treatment
    1