BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 1045422 · Received May 13, 2008

    Report

    Report Number
    1423500-2008-00353
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT REQUIRED FOR EVAL. THIS INCIDENT IS DUE TO A USE ERROR. THERE ARE NO FURTHER MEASURES TO BE TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE AND QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND WILL TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A HOME PT (HP) CONTACTED BAXTER'S TECH SVC CTR REGARDING A LEAKING HOMECHOICE (HC) CASSETTE DURING FILL CYCLE OF THERAPY. PER INITIAL REPORT, BAXTER'S TECH SVC REP (TSR) ASSISTED THE CUSTOMER DURING THE INITIAL CONTACT. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. THE PT NEEDED TO GET CASSETTE OUT. THE HP WAS IN FILL CYCLE. THE FILL VOLUME WAS 793ML. THE HP STATED THAT THE PT LINE STARTED LEAKING. THE TSR ASSISTED HP IN ENDING THERAPY. HC OK. THIS WRITER CALLED THE PT AND REQUESTED INCIDENT DETAILS. THE PT SAID THAT HER PET CAT WAS IN THE ROOM. THE CAT HAD CHEWED ON THE PT LINE CAUSING A LEAK. THE PT DID MENTION THAT SHE WAS NOT CONNECTED TO THE CYCLER AND WAS IN PRIME CYCLE OF THERAPY. THE NURSE WAS ALSO CONTACTED AND MADE AWARE OF THE REASON FOR THE LEAK. THE NURSE SAID THAT THE PT WAS VERY AWARE OF CONTAMINATION ISSUES AND WAS VERY PARTICULAR ABOUT PREVENTING INFECTION. THE NURSE SAID THAT THE PT WOULD HAVE CONTACTED THEM IF THERE WAS A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE 4 PRONG CASSETTE/78FKK FKK BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1