BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2003323 · Received March 1, 2011

    Report

    Report Number
    1423500-2011-02557
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 11, 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 REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOTS (GD880799, GD879916) WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 4 FOR THIS INCIDENCE OF PERITONITIS. AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. FOLLOW UP INFORMATION WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PATIENT CONTACTED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE REGARDING AN UNRELATED ALARM AND REPORTED THAT HE HAD PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM A PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2011: THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2011 BUT WAS NOT HOSPITALIZED. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE NURSE INDICATED THE PATIENT'S PD EFFLUENT WAS ANALYZED (SAMPLING TAKEN ON (B)(6) 2011) BUT THE RESULTS WERE NOT AVAILABLE. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE NURSE INDICATED THE PATIENT WAS TREATED WITH ANTIBIOTICS (DETAILS NOT PROVIDED) AND HAS RECOVERED. THE NURSE DID NOT KNOW IF THE TRANSFER SET WAS REPLACED AFTER THE DIAGNOSIS. THERE WAS NO ALLEGATION MADE AGAINST ANY OF THE PATIENT'S PD SOLUTIONS OR DISPOSABLES. NO FURTHER INFORMATION IS AVAILABLE

    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 79 YR Required Intervention LOCAL PD4 AMBUFLEX| LOCAL PD4 ULTRABAG| HOME CHOICE CYCLER