BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2183461 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09957
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PARTICULATE MATTER WAS CONFIRMED IN THE LAB. THE RESULTS OF A SAMPLE EVALUATION REVEALED EMBEDDED PARTICLES IN THE CASSETTE ON THE OUTSIDE OF TUBING AND ORGANIZER. THE RESULTS OF A BATCH REVIEW REVEALED NO PROBLEMS DURING THE MANUFACTURING PROCESS AND NO DEVIATIONS FROM STANDARD PROCEDURE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. A CAUSE WAS NOT IDENTIFIED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS WRITER RECEIVED A CALL ON (B)(4) 2011 FROM THE HOMECHOICE SERVICE REPRESENTATIVE (HCSR) REGARDING A CASSETTE ISSUE. THEY STATED THEY RECEIVED A CALL FROM THE CUSTOMERS PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) ABOUT THIS DAMAGED CASSETTE. THE HCSR WAS TOLD BY THE PD RN THAT THE CASSETTE AROUND THE FILM AREA HAD STRANGE BLACK DOTS. THE HCSR STATED THE CUSTOMER PROVIDED THE SAMPLES TO THE PD RN, SO THE SAMPLES ARE AVAILABLE FOR EVALUATION. THEY STATED THAT THIS CASSETTE ISSUE DID NOT HINDER THERAPY; THEY FOUND THE PROBLEM DURING SETUP. THE PATIENT WAS NOT CONNECTED. THE DATE IN WHICH THE REPORTED PROBLEM DISCOVERED WAS UNKNOWN. THE HCSR PROVIDED THIS WRITER WITH THE LOT NUMBER H11C15082. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE PD RN STATED THE CASSETTE HAD STRANGE DOTS ON THE FILM OF THE CASSETTE. THE PD RN STATED THEY TRIED TO WIPE IT OFF BUT IT WOULD NOT WIPE OFF. THEY ALSO STATED THAT IT SEEMED TO BE SANDWICH BETWEEN THE TWO FILM MEMBRANES OF THE CASSETTE. THE PD RN STATED THE CARE GIVER (CG) REPORTED THIS PROBLEM TO THEM EARLIER THIS WEEK DURING THEIR CLINIC VISIT. THEY STATED THE PATIENT WAS NOT AFFECTED; THEY DID NOT USE THIS CASSETTE FOR THERAPY. THE PD RN WAS WILLING TO PROVIDE THE SAMPLE TO BAXTER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11C15082

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO HOMECHOICE