BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2201220 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10568
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    February 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE REPORTED THAT ON (B)(6) 2011, THE PATIENT WENT TO THE EMERGENCY ROOM WITH CLOUDY EFFLUENT, AND WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS TREATED WITH VANCOMYCIN (2GM, IP, WEEKLY, FOR 4 WEEKS) AND FORTAZ (1GM, IP, FREQUENCY NOT REPORTED.). DIANEAL THERAPIES WERE ONGOING. A CAUSALITY STATEMENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    INITIALLY, THE PATIENT CALLED THE BAXTER TECHNICAL REPRESENTATIVE REGARDING A 2240 ALARM. DURING A FOLLOW-UP CALL TO THE PATIENT'S NURSE, THE NURSE STATED THE PATIENT HAD EXPERIENCED AN EPISODE OF PERITONITIS IN (B)(6) 2011 FOR WHICH THE PATIENT WAS HOSPITALIZED. DURING A FOLLOW UP CALL TO THE FACILITY NURSE, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT WAS TREATED WITH VANCOMYCIN 2G AND FORTAZ 1G INTRAPERITONEAL. THE CAUSE OF THE PERITONITIS WAS RELATED TO TOUCH CONTAMINATION BY THE PATIENT OF THE CASSETTE TUBING. THIS PATIENT HAS POOR VISION AND LIMITED FAMILY SUPPORT WITH HIS THERAPY. THE PATIENT WAS RETRAINED AND HAS BEEN RETRAINED MULTIPLE TIMES. THE PATIENT REPORTEDLY EXPERIENCED PERITONITIS IN (B)(6) 2010 , (B)(6) 2011 AND (B)(6) 2011 WITH THE SAME SCENARIO OCCURRING. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R DIANEAL LOW CALCIUM, (B)(4) DEXTROSE 5L/5L| DIANEAL LOW CALCIUM, (B)(4) DEXTROSE 5L/5L| DIANEAL LOW CALCIUM, (B)(4) UB DEXTROSE 3L/5L| DIANEAL LOW CA (B)(4) 6L/6L| DIANEAL LOW CA (B)(4) 5L/5L| HOMECHOICE| DIANEAL LOW CA (B)(4) 6L/6L| DIANEAL LOW CALCIUM, (B)(4) UB DEXTROSE 3L/5L| DIANEAL LOW CA (B)(4) 5L/5L| DIANEAL LOW CA (B)(4) 6L/6L| DIANEAL LOW CALCIUM, (B)(4) UB DEXTROSE 3L/5L| DIANEAL LOW CALCIUM, (B)(4) DEXTROSE 6L/6L| DIANEAL LOW CA (B)(4) 5L/5L| DIANEAL LOW CALCIUM, (B)(4) DEXTROSE 5L/5L