BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2231280 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11564
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 15, 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). 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. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD885293, GD884452 AND GD883520 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WHICH RESULTED IN THE PERITONITIS WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT FROM THE USA OF A PATIENT WHO MADE A MISTAKE / TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE / TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS PATIENT MADE MISTAKE / TOUCH CONTAMINATION. TREATMENT INFORMATION WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE EVENT OF PATIENT MADE MISTAKE / TOUCH CONTAMINATION WAS NOT REPORTED. THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION. A SEARCH OF (B)(4) FOR SUSPECT PRODUCTS SHIPPED WITHIN TWO MONTHS BEFORE THE INCIDENT SHOWED THE FOLLOWING: (B)(4), LOT NUMBERS GD885293,GD884452 AND GD883520.

    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 Hospitalization DIANEAL PD4 ULTRABAG