BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT EXCHANGE DEVICE

    MDR report key: 2081983 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05633
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE LOT NUMBER WAS UNKNOWN AND THE SAMPLE WAS NOT AVAILABLE, A BATCH REVIEW WAS NOT PERFORMED. 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.

    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 FOURTH OF FOUR REPORTS ASSOCIATED WITH THIS EVENT

    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) 2011AND 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 COMPACT EXCHANGE DEVICE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention HOME CHOICE| LOWCAL (PD4) AMBUFLEX| LOWCAL (PD4)ULTRABAG