BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAT EMUL 1.6 CAS CP

    MDR report key: 1943981 · Received December 3, 2010

    Report

    Report Number
    9615050-2010-00245
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 CONTACT REPORTED A DISCONNECTION. THE MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO Q-SYTE LUER ACCESS SPLIT SEPTUM DEVICE. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF HEPARIN VIA A PLUM A+ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE REPORTED THAT THE TUBING SET DISCONNECTED FROM THE Q-SYTE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS 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 FAT EMUL 1.6 CAS CP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ PUMP: LIST #12391, SN UNK| (B)(4)| Q-SYTE LUER ACCESS SPLIT SEPTUM: (B)(4)