BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 4121412 · Received July 28, 2014

    Report

    Report Number
    8030665-2014-00577
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S HUSBAND REPORTED FINDING A FLUID LEAK FOLLOWING HIS WIFE'S TREATMENT. HE WAS PREPARING THE CYCLER FOR HER NEXT TREATMENT WHEN HE REMOVED THE CASSETTE AND FOUND A FLUID LEAK. THE PATIENT WAS SWITCHED TO MANUAL TREATMENT. THE SET WAS DISCARDED. DURING FOLLOW UP, THE PATIENT'S HUSBAND REPORTED THAT HIS WIFE HAD PASSED AWAY (B)(6) 2014. DURING ADDITIONAL FOLLOW UP, THE PATIENT'S PD NURSE REPORTED THAT THE PATIENT DID NOT REQUIRE INTERVENTION FOR THIS LEAK INCIDENT. HER DEATH WAS NOT RELATED TO THIS EVENT OR HER PD TREATMENT. SHE HAD BEEN REMOVED FROM PD TREATMENT THE DAY BEFORE HER PASSING DUE TO UNRELATED PRE-EXISTING MEDICAL CONDITIONS AND EXTENDED ILLNESS. THE NURSE REPORTED SHE HAD DIFFICULTY EATING OR SWALLOWING WHICH CONTRIBUTED TO HER PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440058 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13SR08059

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTIONS| LIBERTY CYCLER