BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2142262 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08425
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE SAMPLE LOT NUMBER IS KNOWN, THEREFORE A BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT A LEAKING WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING THERAPY. THE HOME PATIENT (HP) STATED THAT HE THOUGHT THAT THERE WAS A PROBLEM WITH THE CASSETTES. THE HP STATED THAT WHEN HE WAS DONE THERAPY IN THE MORNING A FEW TIMES HIS BED WAS WET. THE HP PROVIDED WITH THE LOT # H11B21066. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE TSR HAD THE CARE GIVER (CG) CHECK FOR LEAKS. THE CG STATED THAT THE CATHETER WAS LEAKING. THE CG REQUESTED TO END CALL AND IMMEDIATELY CALL THE DOCTOR. THE TSR EXPLAINED TO POWER THE HC OFF AND CALLBACK LATER IF NEEDED ASSISTANCE TO END THERAPY. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. (B)(4) CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED ISSUE. THE HOME PATIENT (HP) STATED THE LEAK WAS WHERE THE CATHETER CONNECTED TO THE CASSETTE. THE HP STATED THAT IT LOOKED LIKE THE CONNECTION ON THE CASSETTE WAS BENT AND THAT IT MIGHT HAVE BEEN A MANUFACTURING ISSUE THAT CAUSED THE LEAK. THE HP STATED THE SAMPLE WAS DISCARDED AND HE IS CURRENTLY USING NEW CASSETTES FROM THE DIALYSIS CENTER SO A COMPANION SAMPLE WAS NOT AVAILABLE. THE HP CONFIRMED THAT HE DISCOVERED THE LEAK AFTER FINDING HIS BED WET IN THE MORNING. THE HP STATED SINCE USING NEW CASSETTES THERAPY HAS BEEN GOING FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11B21066

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE