BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIF MK W/DT4 W/SS 84

    MDR report key: 1470374 · Received August 3, 2009

    Report

    Report Number
    9615050-2009-00168
    Event Type
    Malfunction
    Date Received
    August 3, 2009
    Date of Event
    July 20, 2009
    Report Date
    July 21, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    KRA
    PMA / PMN Number
    K932188
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRACK; SUBSEQUENTLY A LEAK WAS NOTED. THE MONITORING KIT WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE WHILE THE NURSE WAS IN THE PATIENT'S ROOM, IT WAS REPORTED THAT THE NURSE HEARD "SNAP" AND NOTED A LEAK OF SOLUTION FROM A CRACK BETWEEN THE TRANSDUCER AND STOPCOCK. THE NURSE PLACED HER FINGER OVER THE CRACK TO STOP THE LEAK. THE MONITORING KIT WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIF MK W/DT4 W/SS 84 74KRA KRA HOSPIRA COSTA RICA LTD. NA 714115G

    Patients

    Seq Age Sex Outcome Treatment
    1