BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT DENVER ASCITES PAK DOUBLE VALVE

    MDR report key: 4131615 · Received October 1, 2014

    Report

    Report Number
    1625685-2014-00135
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    KPM
    PMA / PMN Number
    K011862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO AN FDA INSPECTION ((B)(4)), CAREFUSION 2200 INITIATED A CAPA INVESTIGATION (CAPA IS (B)(4)). AS PART OF THE CAPA, A RETROSPECTIVE REVIEW OF THE COMPLAINTS FOR "DEBRIS" AND "CONTAMINATION" FOR APPLICABLE DEVICES WAS CONDUCTED. IT WAS DETERMINED THAT THIS REPORT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORT (MDR). EVALUATION SUMMARY: ONE (1) UNOPENED SAMPLE WAS PROVIDED FOR EVALUATION. EVALUATION OF THE COMPLAINT SAMPLE CONFIRMED THE PRESENCE OF A LOOSE FLAKE OF SILICONE ADHESIVE ON THE EXTERIOR WALL OF THE CHAMBER. IT HAS BEEN IDENTIFIED THAT THIS FAILURE MODE IS NOT AN ISOLATED EVENT. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES IDENTIFIED A SPECIFIC MANUFACTURING STEP THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A DEVICE HISTORY RECORD (DHR) REVIEW, RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS A PROCESS ERROR (LOOSE SILICONE ADHESIVE GENERATED DURING THE MANUFACTURING OF THE AFFECTED UNIT WITHIN LOT 0000478616), WHICH GENERATED THE CONFIRMED FAILURE MODE OF A LOOSE FLAKE OF SILICONE ADHESIVE ON THE EXTERNAL SURFACE OF THE SHUNT CHAMBER. THE MANUFACTURING PLANT HAS ALSO INITIATED A CAPA INVESTIGATION (B)(4)) TO ADDRESS THE REPORTED ISSUE. ALL CORRECTIVE AND PREVENTIVE ACTIONS (INCLUDING MANUFACTURING AND QUALITY PLAN IMPROVEMENTS) WILL BE IMPLEMENTED PER THE CAPA.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION, THE CUSTOMER NOTED THAT THERE SEEMS TO BE A SCAR ON THE PERITONEAL TUBING NER THE PUMP CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612533 SHUNT DENVER ASCITES PAK DOUBLE VALVE SHUNT, PERITONEAL KPM CAREFUSION 42-2050 0000478616

    Patients

    Seq Age Sex Outcome Treatment
    1