BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONN. SL

    MDR report key: 2498541 · Received March 15, 2012

    Report

    Report Number
    9613251-2012-00038
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 14, 2012
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K052722. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE TUBING SET WAS BEING USED FOR ARTERIAL BLOOD PRESSURE MONITORING. THE MALE ADAPTER OF AN UNSPECIFIED PRESSURE MONITORING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE TUBING SET. THE T-CONNECTOR OF THE TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE PT'S ARTERIAL CATHETER. IT WAS REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME, THE T-CONNECTOR DISCONNECTED FROM THE ARTERIAL ACCESS SITE AND THE PT'S ARTERIAL BLOOD PRESSURE COULD NOT BE MEASURED. THE TUBING SET WAS REPLACED AND THE MONITORING WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET WITH T-CONN. SL UNK FPA HOSPIRA, LTD. NA UNKNY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED IV CATHETER: MFR UNK| UNSPECIFIED PRESSURE MONITORING KIT: MFR UNK