BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PLUM PRIMARREGULAR PUMP SET 5000 - XL

    MDR report key: 2093327 · Received April 15, 2011

    Report

    Report Number
    9615050-2011-00264
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 18, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    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. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING SUED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS DISCONNECTED FROM AN UNSPECIFIED ANESTHESIA EXTENSION SET. IT WAS REPORTED THAT DURING THE MANIPULATION, THE TUBING SEPARATED FROM THE OPTION-LOK MALE ADAPTER. THE TUBING SET WAS REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS PLUM PRIMARREGULAR PUMP SET 5000 - XL 80FRN FRN HOSPIRA COSTA RICA LTD NA 870915H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK