BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5218431 · Received November 11, 2015

    Report

    Report Number
    9616066-2015-01405
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXTER HEALTHCARE CORPORATION, 50ML BAG OF 5% DEXTROSE INJECTION USP, LOT P336263, EXP JUNE 2016; (B)(4), VIAL OF CEFTRIAXONE FOR INJECTION, USP 1G/VIAL (LOT 156085.1, EXP 07/2018); THERAPY DATE: (B)(6) 2015. THE CUSTOMER¿S REPORT OF A DAMAGED TUBING COMPONENT WAS CONFIRMED. VISUAL INSPECTION OF THE PRIMARY SET¿S DISTAL LUER LOCK FOUND THAT THE SPIN COLLAR WAS CRACKED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE OBVIOUS DAMAGE. ANALYSIS AND TESTING OF COMPONENT SAMPLES FROM SIMILAR REPORTS HAS DETERMINED THE DAMAGE WAS LIKELY DUE TO A BRITTLE FAILURE. THE ROOT CAUSE OF THE DAMAGED TUBING COMPONENT WAS IDENTIFIED AS A DEFECTIVE LUER COLLAR COMPONENT. A MANUFACTURING CORRECTIVE ACTION AND FIELD ACTION HAVE BEEN IMPLEMENTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MALE LUER OF THE PRIMARY TUBING CRACKED INTO SEVERAL PIECES WHILE TRYING TO CONNECT IT TO THE END OF A J LOOP. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747567 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0500 15095332

    Patients

    Seq Age Sex Outcome Treatment
    1