BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2081828 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05627
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 13, 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 EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H10J16046 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER CONTACTED THE CAREGIVER (CG) REGARDING AN UNRELATED ALARM. THE CG STATED THAT PERITONEAL DIALYSIS(PD) HAD BEEN DISCONTINUED ON THE HOMEPATIENT(HP) AS HE WAS DIAGNOSED WITH PERITONITIS IN (B)(6) 2011. ON (B)(6) 2011, BAXTER SPOKE TO THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THAT THE HP ALSO HAD THE PD CATHETER REMOVED IN (B)(6) 2011 AND WAS PLACED ON HEMODIALYSIS. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. A CAUSALITY STATEMENT WAS NOT GIVEN, BUT THE PDRN STATED THAT THE BAXTER DEVICES OR SOLUTIONS WERE NOT RELATED.

    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 57 YR Required Intervention LOWCAL (PD4) ULTRABAG| HOME CHOICE| LOWCAL (PD4) AMBUFLEX