BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2072228 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05167
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD882241 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

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (LOT NUMBER, DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS FROM AN UNKNOWN CAUSE. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. UPON A FOLLOW-UP CALL WITH THE PATIENT'S NURSE, THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 82 YR Other DIANEAL PD4 ULTRABAG