BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAT EMUL 1.6 CAS CP

    MDR report key: 1943983 · Received December 3, 2010

    Report

    Report Number
    9615050-2010-00241
    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 DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DISCONNECTIONS. THE MALE ADAPTERS OF THE TUBING SETS WERE CONNECTED TO Q-SYTE LUER ACCESS SPLIT SEPTUM DEVICES AND WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS VIA PLUM A+ PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE TUBING SETS DISCONNECTED FROM THE Q-SYTE DEVICES. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPY CRITICAL TO THESE PTS. 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 Q-SYTE LUER ACCESS SPLIT SEPTUMS: (B)(4)| (B)(4)| PLUM A+ PUMPS: LIST #12391, SN UNK