BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM CONV PN INTGRL F

    MDR report key: 1970971 · Received January 6, 2011

    Report

    Report Number
    9615050-2011-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    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
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. 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 CONNECTIONS 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 (B)(4) 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 COMPLAINTS. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER 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 VIA AN UNSPECIFIED PLUM PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECOND PLUMSET WAS CONNECTED TO THE DISTAL CLAVE Y-SITE OF THE PRIMARY PLUMSET TO DELIVER AN UNSPECIFIED CONCENTRATION OF PACLITAXEL VIA A SECOND UNSPECIFIED PLUM PUMP. IT WAS REPORTED THAT 15 MINUTES AFTER THE PACLITAXEL DELIVERY WAS INITIATED AT AN UNSPECIFIED LOW RATE, THE NURSE RETURNED TO THE PT AND NOTED A SMALL VOLUME OF FLUID LEAKAGE. IT WAS REPORTED THAT THE LEAK HAD FORMED A WET SPOT THE SIZE OF QUARTER ON THE PT'S PANTS. THE PANTS WERE REMOVED AND THE UNDERLYING SKIN WAS WASHED WITH SOAP AND WATER. THE SKIN WAS EXAMINED AND NO MEDICAL INTERVENTIONS WERE REQUIRED. AFTER THE LEAK WAS NOTED, THE NURSE ATTEMPTED TO RETIGHTEN THE OPTION-LOK MALE ADAPTER TO THE CLAVE Y-SITE. IT WAS REPORTED THAT THE MALE ADAPTER BROKE OFF INSIDE THE CLAVE Y-SITE. THE TUBING SETS AND PACLITAXEL CONTAINER WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM CONV PN INTGRL F 80FRN FRN HOSPIRA COSTA RICA LTD. NA 910705H

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # UNK| LIFESHIELD PRIMARY I.V. PLUMSET, LIST # 11943