BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2072217 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05154
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (H10J23034 AND H10I07020) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS.

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF FELT SICK AND PERITONITIS IN A (B)(6) MALE COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (LOT NUMBER, DOSAGE AND FREQUENCY NOT REPORTED) AND DIANEAL PD4 ULTRABAG (LOT NUMBER, DOSAGE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IN (B)(4) AND "FELT SICK A COUPLE OF DAYS BEFORE THEY LEFT." THE PATIENT HAD BOUGHT PD PRODUCTS (PRODUCT, LOT NUMBER, DOSAGE AND FREQUENCY NOT REPORTED) FROM A DISTRIBUTOR IN (B)(4). IN (B)(6) 2011, THE PATIENT RETURNED TO THE USA. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE, THE PERITONEAL DIALYSIS WAS WITHDRAWN. ON AN UNREPORTED DATE, THE PATIENT BEGAN HEMODIALYSIS. THE CONSUMER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX