BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 7997254 · Received October 23, 2018

    Report

    Report Number
    9616066-2018-01990
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    September 26, 2018
    Report Date
    September 27, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403227998
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A HOLE AND LEAKING WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT THE SILICONE SEGMENT HAD A TEAR NEAR THE UPPER FITMENT MEASURING 0.0236 INCHES LONG. EXAMINATION UNDER MAGNIFICATION SHOWED NO CRUSH MARKS TO THE UPPER FITMENT. FUNCTIONAL AND PRESSURE TESTING WAS PERFORMED; A LEAK FROM THE SILICONE TUBING NEAR THE UPPER FITMENT WAS OBSERVED. THE CAUSE OF THE LEAK WAS A TEAR IN THE SILICONE SEGMENT. THE CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TUBING SET HAD A HOLE IN THE SILICONE SEGMENT OF THE TUBING WHICH CAUSED AN ANTIBIOTIC MEDICATION TO LEAK DURING A GRAVITY INFUSION TO THE PATIENT. THE NURSE CONTACTED THE PHYSICIAN TO RECEIVE ANOTHER ORDER FOR THE MISSED/LEAKED ANTIBIOTIC DOSE. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TUBING SET HAD A HOLE IN THE SILICONE SEGMENT OF THE TUBING WHICH CAUSED AN ANTIBIOTIC MEDICATION TO LEAK DURING A GRAVITY INFUSION TO THE PATIENT. THE NURSE CONTACTED THE PHYSICIAN TO RECEIVE ANOTHER ORDER FOR THE MISSED/LEAKED ANTIBIOTIC DOSE. THERE WAS NO PATIENT HARM.

    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 THAT THE TUBING SET HAD A HOLE IN THE SILASTIC SEGMENT OF THE TUBING WHICH CAUSED AN ANTIBIOTIC MEDICATION TO LEAK DURING A GRAVITY INFUSION TO THE PATIENT. THE NURSE CONTACTED THE PHYSICIAN TO RECEIVE ANOTHER ORDER FOR THE MISSED/LEAKED ANTIBIOTIC DOSE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838300 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007 18086440 10885403227998

    Patients

    Seq Age Sex Outcome Treatment
    1 MS3500