BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM LC OL CNVRTBL P

    MDR report key: 1963439 · Received December 20, 2010

    Report

    Report Number
    9615050-2010-00268
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED FOUR POSSIBLE LOT NUMBERS. THE POSSIBLE LOT NUMBERS ARE 920125H, 910235H, 910245H, AND 881995H. HOSPIRA HAD COMPLETED A FORMAL INVESTIGATION TO ADDRESS SIMILAR COMPLAINTS DUE TO SPIN COLLAR OPTION-LOK CONNECTION PROBLEMS WITH OTHER DEVICES WHICH RESULTED IN LEAKS, CRACKS AND GENERAL CONNECTION EVENTS. BASED UPON THE INVESTIGATION RESULTS, HOSPIRA HAS IDENTIFIED THAT IT NEEDS TO MAKE DIMENSIONAL CHANGES TO THE SPIN COLLAR THAT WILL IMPROVE THE COMPLIANCE WITH THE ISO STANDARD (594-2) AND INTERACTION WITH OTHER COMPONENTS. THE PLANNED IMPROVEMENTS WILL OPTIMIZE THE DESIGN OF THE THREAD, TAPER AND TAPER PROTRUSION OF THE OPTION-LOK TO MINIMIZE IDENTIFIED FAILURE MODES AND RESULTANT COMPLAINT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE PRIMARY PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECOND PLUMSET WAS CONNECTED TO THE CLAVE Y-SITE OF THE PRIMARY PLUMSET FOR DELIVERY OF AN UNSPECIFIED VOLUME OF OXALIPLATIN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED LEAKAGE OF THE CHEMOTHERAPEUTIC AGENT AT THE CONNECTION OF THE OPTION-LOK MALE ADAPTER AND THE CLAVE Y-SITE. AN UNSPECIFIED VOLUME OF SOLUTION LEAKED ONTO THE PT'S SKIN. THE SKIN WAS REPORTED TO BE RED AND WAS WASHED WITH SOAP. THE SPILL WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAY IN THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM LC OL CNVRTBL P 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 LIFESHIELD IV PLUMSET, LIST #12030, LOT #UNK