BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4230919 · Received October 15, 2014

    Report

    Report Number
    9616066-2014-01046
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEFECTIVE IV TUBING ISSUE. D5 1/2NSS WITH THIAMINE 100MG, FOLIC ACID 1MG, MULTIVITAMIN WITH VITAMIN K 10ML WAS RUNNING AT 50ML/HR. WHEN THE PATIENT RETURNED FROM ULTRASOUND THE PUMP WAS BEEPING. THE PICC LINE WAS SLUGGISH BUT WAS ABLE TO BE FLUSHED. WHEN THE DOOR TO THE PUMP WAS OPENED THERE WAS A 1 INCH BULGE AT THE TOP OF THE SILICONE SEGMENT. 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
    652620 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ALARIS PCU: SN UNK| PICC LINE: MFR/MODEL/LOT UNK| ALARIS PUMP MODULE: SN UNK