BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1901181 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05847
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER(S); H10G25042, H10D13052, AND H10B12108 WITH NO DEFECTS NOTED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(4) OF ACUTE MYOCARDIAL INFARCTION (MI), PERITONITIS, SEPSIS AND ILEUS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010 THE PATIENT WAS HOSPITALIZED FOR AN ACUTE MI, PERITONITIS AND SEPSIS. ON AN UNREPORTED DATE, WHILE HOSPITALIZED, THE PATIENT DEVELOPED AN ILEUS. THE PATIENT UNDERWENT A STENT PLACEMENT FOR THE ACUTE MI AND RECEIVED (B)(6) WHILE HOSPITALIZED FOR THE PERITONITIS AND SEPSIS. THE NURSE PROVIDED AN ALTERNATIVE ETIOLOGY OF THE ACUTE MI LEADING TO AN ILEUS LEADING TO PERITONITIS AND SEPSIS. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE EVENTS OF ACUTE MI, PERITONITIS AND SEPSIS WERE RESOLVED. THE OUTCOME FOR THE ILEUS WAS NOT REPORTED. PD THERAPY WAS ONGOING. THE NURSE BELIEVED THE EVENTS OF ACUTE MI, PERITONITIS AND SEPSIS WERE UNRELATED TO PD THERAPY AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE ILEUS.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE METER DISPLAYED UNKNOWN ERRORS AND DISPLAYED ERROR 5. THESE ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DIANEAL PD4 AMBUFLEX