BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2191059 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10259
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBERS (GD883082 AND GD884445) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, 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 SECOND OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER TECHNICAL SERVICES FOR ASSISTANCE IN DISCONNECTING BECAUSE THE HOME PATIENT (HP) HAD PERITONITIS AND NEEDED TO SEE THE RN. BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 REGARDING THE CG REPORT OF BACTERIAL PERITONITIS. THE PDRN STATED THAT ON (B)(6) 2011, THE HP EXHIBITED SYMPTOMS AND CAME TO THE CLINIC. PERITONEAL DIALYSIS (PD) EFFLUENT ANALYSIS WAS PERFORMED. INTRAPERITONEAL (IP) ANTIBIOTIC TREATMENT WAS INITIATED THAT SAME DAY, BUT SHE WOULD NOT DISCLOSE FURTHER INFORMATION. A CAUSALITY STATEMENT WAS NOT GIVEN.

    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 75 YR Required Intervention LOCAL(PD4)AMBUFLEX| LOCAL(PD4)ULTRABAG| HOME CHOICE