BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2143429 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08488
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 7, 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 CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD882647 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. 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). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE PATIENT CONTINUED TO EXPERIENCE PERITONITIS AND WAS HOSPITALIZED ON (B)(6) 2011. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT DURING HOSPITALIZATION WAS NOT REPORTED. THE PATIENT WAS RECOVERING AND PD THERAPY WAS ONGOING.THE NURSE STATED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION. A SEARCH OF (B)(6) FOR SUSPECT PRODUCTS SHIPPED WITHIN TWO MONTHS BEFORE THE INCIDENT SHOWED THE FOLLOWING: (B)(4), LOT NUMBER GD882647.

    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 59 YR Hospitalization| R DIANEAL PD4 ULTRABAG