BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SSINGLE CONN./EXT. DL

    MDR report key: 2241694 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00048
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 14, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSA MFG.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87216 LOT# 10KR08002 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: - THE 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 RE-WORKS/RE-INSPECTIONS WERE PERFORMED TO THIS FINISHED GOODS LOT OF 10KR08002. SAMPLE ANALYSIS: NO SAMPLE WAS AVAILABLE FOR THE EVAL. CONCLUSIONS: THE COMPLAINT IS NOT CONFIRMED. UNFORTUNATELY WITHOUT THE COMPLAINT SAMPLE IT IS NOT POSSIBLE TO PERFORM AND INVESTIGATION TO IMPLEMENT APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS THAT LEAD TO AVOID THIS TYPE OF INCIDENT. (B)(4) WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT PER PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT WHEN SHE HAD REMOVED THE CASSETTE FROM THE MACHINE SHE NOTICED A FLUID LEAK. THIS WSA NOTICED WHEN SHE DISCONTINUED TREATMENT. THERE IS NO REPORT OF ILL EFFECT. THE SAMPLE WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SSINGLE CONN./EXT. DL PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MFG. NA 10KR08002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE