BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 4063100 · Received August 8, 2014

    Report

    Report Number
    8030665-2014-00612
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    FRESENIUS REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S SPOUSE REPORTED FINDING A LEAK NEAR THE CONNECTION BETWEEN THE PATIENT'S CATHETER AND THE PATIENT LINE DURING DRAIN 3 OF 6. THERE APPEARED TO BE A BREAK NEAR THE PIN. SHE TRIED REPAIRING THE CONNECTION, BUT WAS NOT SUCCESSFUL. SHE DISCONTINUED TREATMENT AND CONTACTED THE PATIENT'S PD NURSE. THE SET WAS RETAINED AND IS BEING MADE AVAILABLE FOR EVALUATION. DURING FOLLOW UP, THE PATIENT'S PD NURSE REPORTED THAT HIS EFFLUENT REMAINED CLEAR. HE DID NOT HAVE ANY SIGNS OF INFECTION. HE WAS PRESCRIBED ONE DOSE OF PROPHYLACTIC ANTIBIOTICS VANCOMYCIN AND FORTAZ. SHE REPORTED THAT THE PATIENT IS ELDERLY WITH DEMENTIA AND SUN DOWN SYNDROME. HIS WIFE REPORTED HE MOVED A LOT THAT NIGHT AND LIKELY BROKE THE CONNECTOR HIMSELF WHILE CONFUSED. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470646 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX FRESENIUS REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER