BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2201048 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10561
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (GD882639 ) 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 WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A CALL TO THE BAXTER SERVICE REPRESENTATIVE, THE PATIENT INDICATED HE MAY HAVE AN INFECTION AND WAS ADVISED BY THE FACILITY NURSE, TO ADD MEDICATION TO THE PERITONEAL DIALYSIS (PD) SOLUTION. A FOLLOW UP CALL WAS MADE TO THE FACILITY NURSE ON (B)(6) 2011, WHO CONFIRMED THE PATIENT HAD BEEN DIAGNOSED WITH PERITONITIS. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT WAS HOSPITALIZED. THE PATIENT IS CURRENTLY OFF PD AND IS RECEIVING HEMODIALYSIS UNTIL HIS ABDOMINAL AND INTESTINAL ISSUES (UNKNOWN) ARE RESOLVED. SUSPECT LOT: GD882639.

    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 76 YR Hospitalization| R DIANEAL LOW CAL, SINGLE BAG DEXTROSE 4.250%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 2.50%...| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50%...| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 4.25%...| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 2.50%| HOMECHOICE