BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2141539 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08393
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (GD884445 ) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED. THIS IS SECOND OF TWO REPORTS ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    INITIALLY, THE HUSBAND CALLED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) FOR ASSISTANCE DURING THERAPY. DURING A FOLLOW UP CALL, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING THE REPORTED EVENT. THE RN STATED THAT THE PATIENT WAS ON ANTIBIOTICS DUE TO PERITONITIS CAUSED BY (B)(6). THE RN DID NOT KNOW IF THE CAUSE WAS RELATED TO THE PATIENT'S PERITONEAL DIALYSIS. THE NURSE STATED THE PATIENT WAS CONTINUING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention HOMECHOICE| LOW CA 2.5% 2L/2L UB DIANEAL| LOW CA 1.5% 2L/2L UB DIANEAL| LOW CA 1.5% 5L/5L DIANEAL| LOW CA 4.25% 2L/2L UB DIANEAL| LOW CA 2.5% 5L/5L DIANEAL| LOW CA 4.25% 5L/5L DIANEAL