BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2201096 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10564
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 25, 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). DURING A FOLLOW UP CALL TO THE FACILITY NURSE, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2011. THE PATIENT WAS PLACED ON UNKNOWN ANTIBIOTICS. THE FACILITY NURSE BELIEVED THE PERITONITIS WAS CAUSED BY TOUCH CONTAMINATION AND RETRAINING WAS PERFORMED. THE PATIENT HAS RECOVERED FROM THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (GD883967 AND GD884437) 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.

    Description of Event or Problem · 1

    INITIALLY, THE PATIENT CALLED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE REGARDING A CHECK PATIENT LINE ALARM. DURING THE CALL, THE PATIENT INDICATED THAT HE IS ADDING ANTIBIOTICS TO HIS FINAL SOLUTION BAG DUE TO PERITONITIS. SUSPECT LOT NUMBERS: GD883967 AND GD884437.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| EXTRANEAL, SINGLE BAG (B)(4) ICODEXTRIN| DIANEAL LOW CAL, ULTRA BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| HOMECHOICE| DIANEAL LOW CAL, ULTRA BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, ULTRA BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)