BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1839390 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03542
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT FOR THE CASSETTE (H10E29048) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. 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 IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS AND GI BLEED IN AN APPROXIMATELY (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WENT TO THE ER AND WAS DIAGNOSED WITH A GI BLEED. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE GI BLEED. THE CAUSE OF THE GI BLEED WAS UNKNOWN. THE PATIENT WAS RECOVERING AND WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS COMPLAINT ORIGINATED AS A RESULT OF A REPORT RECEIVED BY BAXTER (B)(4) FROM (B)(6), DIALYSIS UNIT. IT WAS REPORTED THAT THE CONNECTOR OF THE MINISET TRANSFER SET (CODE: R5C4482, BATCH: UNK) WAS BROKEN AND THE DEVICE COULD NOT BE CONNECTED TO THE BAG OR TO THE IODINE CAP. ONE UNIT WAS IMPACTED. NO PATIENT INVOLVED. SAMPLE IS AVAILABLE.

    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 AMBU-FLEX