BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PA

    MDR report key: 2102915 · Received May 4, 2011

    Report

    Report Number
    8030665-2011-00018
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 7, 2011
    Report Date
    May 4, 2011
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY LOT REVIEW: THE DEVICE HISTORY RECORD REVIEW OF 050-87212 LOT # 10SR08043 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THIS PRODUCT DID NOT HAVE ANY NCR'S. NO DEVIATION WAS DOCUMENTED DURING THE MFG PROCESS. ALL THE APPLICABLE TESTS DURING THE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURES. NO REWORKS/RE-INSPECTIONS WERE PERFORMED TO THIS FINISHED GOODS LOT 10SR08043. SAMPLE ANALYSIS: NO SAMPLE WAS RECEIVED FOR EVAL. CONCLUSION: THE SAMPLE WAS NOT RECEIVED. THE COMPLAINT IS DEEMED AS NOT CONFIRMED. UNFORTUNATELY WITHOUT THE SAMPLE IT IS NOT POSSIBLE TO PERFORM AN INVESTIGATION TO IMPLEMENT APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS THAT LEAD TO THIS TYPE OF INCIDENT. FMC REYNOSA WILL CONTINUE MONITORING THIS TYPE OF INCIDENT PER CURRENT PROCEDURE. NOTE: HAS BEEN DEEMED ON (B)(4) 2011 AFTER A REVIEW OF ALL THE INFO THAT HAS BEEN RECEIVED THIS REPORT WILL BE SUBMITTED AS A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 1

    THIS IS A PEDIATRIC PT WHO IS NEW TO BOTH THE LIBERTY CYCLER AND THE LIBERTY CYCLER SET. THE CLINICAL MGR OF THE PTS PD CLINIC REPORTED THAT DURING TREATMENT THE PT EXPERIENCED MULTIPLE UNRESOLVED PRESSURE LEAK ALARMS AND STATED THAT THE TUBING SETS MAY HAVE BEEN A CONTRIBUTING FACTOR ALTHOUGH A SPECIFIC PRODUCT DEFECT HAS NOT BEEN REPORTED. THEIR CONCERN IS THAT THE PT MAY BE UNDERDIALYZING AS A RESULT. THE CHILD DID ACQUIRE AN EXIT SITE INFECTION UNRELATED TO THE REPORTED EVENT. THE PT HAS BEEN ORDERED A NEWTON CYCLER MACHINE AND TUBING AND IS CURRENTLY RECEIVING TREATMENT WITH NO FURTHER ISSUES/CONCERNS. NO SAMPLE IS BEING SENT BACK FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PA PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MFG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR LIBERTY CYCLER DIALYSIS MACHINE