BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2990083 · Received January 30, 2013

    Report

    Report Number
    9616066-2013-00057
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 15, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED A COPY OF CUSTOMER'S MEDWATCH REPORT STATING "FOUND 2 DIFFERENT IV PUMPS ALARMING DURING SHIFT. IV TUBING DRIPPING TO FLOOR. FOUND HOLE IN BOTH TUBINGS. HOLES ARE LOCATED AT THE TOP OF THE 'PUMP SEGMENT' OF THE TUBING UNDER OR NEAT BLUE PART WHERE TUBING IS ATTACHED." ASSUME STATEMENT OF "NEAT BLUE PART" IS A TYPO MEANING "NEAR BLUE PART WHERE TUBING IS ATTACHED". THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40305 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PUMP MODULE, SNS UNKNOWN| ALARIS PC UNIT, SN UNKNOWN