BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1992138 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01996
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER(S) H10K28064 AND H10J30021 WITH NO DEFECTS NOTED. 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

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT (DATE NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES WERE ONGOING. THE PATIENT WAS RECOVERING FROM THE EVENT AT THE TIME OF REPORTING. PER THE NURSE, THE EVENT OF PERITONITIS WITH (B)(6) WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES.

    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 71 YR Hospitalization DIANEAL PD4 ULTRABAG| HOMECHOICE CYCLER| DIANEAL PD4 AMBUFLEX