BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2924173 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01528
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS COMPLAINT FOR PERITONITIS-NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, AND NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE WERE REPORTED. THE COMPLAINT INVESTIGATION DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. THEREFORE, THE COMPLAINT IS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. A BATCH REVIEW OF THE SUSPECT LOT WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS A REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE OF ABDOMINAL PAIN, NAUSEA, AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS. DURING TROUBLESHOOTING FOR AN UNRELATED EVENT, THE CARE GIVER (CG) REPORTED TO BAXTER TECHNICAL SERVICES THAT THE HOME PATIENT HAD PERITONITIS. NO FURTHER CLINICAL INFORMATION WAS OBTAINED AT THE TIME OF THE INITIAL REPORT. INITIAL CONTACT WITH THE NURSE PROVIDED THE FOLLOWING INFORMATION. ON AN UNKNOWN DATE IN 2012, THE PATIENT HAD EXPERIENCED PERITONITIS, THE CAUSE AND TREATMENT OF WHICH WERE UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED. THE NURSE REPORTED THE PATIENT HAD RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS PROVIDED BY THE CONSUMER ON (B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD EXPERIENCED ABDOMINAL PAIN AND NAUSEA. ON (B)(6) 2012, THE PATIENT'S DIANEAL THERAPY WAS PLACED ON HOLD DUE TO THE EVENTS OF ABDOMINAL PAIN AND NAUSEA. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. TREATMENT INCLUDED AN UNKNOWN ANTIBIOTIC, ADMINISTERED INTRA-PERITONEALLY. ON (B)(6) 2012 DIANEAL THERAPY RESUMED AND ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF ABDOMINAL PAIN, NAUSEA AND PERITONITIS WAS UNKNOWN. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. CONTACT WITH THE PERITONEAL DIALYSIS NURSE (PDN) WAS MADE ON (B)(6) 2013 AND THE PDN CONFIRMED THE INFORMATION PROVIDED BY THE CONSUMER. PER THE NURSE, THE EVENTS OF ABDOMINAL PAIN, NAUSEA, AND PERITONITIS WERE UNRELATED TO DIANEAL THERAPY OR ANY BAXTER MACHINES OR DISPOSABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31422 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12K11506

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R DIANEAL PD2 ULTRABAG| DIANEAL PD2 AMBUFLEX