BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1973131 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01230
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    May 1, 2010
    Report Date
    January 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H09I18046, H09J27061, H09K07012, H09H06035, H09I18079, H09K10032, H09K21435, H09L04058, H10A11029, H09E21063A, H10A23032, H10B01028, AND H10B16042), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING FOLLOW-UP PERFORMED BY (B)(6) ON (B)(6) 2011, REGARDING THE REPORT OF THIS PATIENT PASSING AWAY (WHICH IS UNRELATED TO THIS REPORT), THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: IN 2006, THE PATIENT BEGAN PERITONEAL DIALYSIS USING PD4 AMBUFLEX AND PD4 ULTRA BAG, IP (LOT, DOSE, AND FREQUENCY NOT AVAILABLE). WHEN ASKING THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSE ABOUT PAST MEDICAL HISTORY, THE PD NURSE STATED THE PATIENT HAD AN EPISODE OF PERITONITIS IN (B)(6) 2010. THE PD NURSE DID NOT KNOW THE CULTURE RESULTS. CAUSALITY ASSESSMENT WAS NOT RELATED TO THE DIANEAL SOLUTION. THE PD NURSE HAD NO FURTHER INFORMATION REGARDING THE PERITONITIS. ALL AVAILABLE INFORMATION WAS REPORTED. NO FURTHER INFORMATION WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other HOMECHOICE DEVICE| PD4 AMBUFLEX| PD4 ULTRA BAG