BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180497 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09799
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    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

    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 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER H11D30030, AND H11C30107WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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 GLOBAL PHARMACOVIGILANCE (GPV) AS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT STATED THAT ON AN UNREPORTED DATE IN 2011, HE MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENTS. TREATMENT FOR THE EVENTS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL PD4 ULTRABAG THERAPY WAS NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT PROVIDED. THE PATIENT'S PD NURSE DECLINED TO PROVIDE INFORMATION.

    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 79 YR Other HOMECHOICE| DIANEAL PD4 ULTRABAG