BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2180084 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09716
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 8, 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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD885285, GD884445, GD883967, GD883512 AND GD882647 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 IN (B)(6) OF A PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN AND DIANEAL PD4 AMBUFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT REPORTED THAT HER CAT WAS IN THE ROOM WHILE HOOKING UP AND THAT MAY HAVE BEEN THE CAUSE OF THE PERITONITIS. THE NURSE REPORTED THE CAUSE OF PERITONITIS WAS THAT THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECOVERED FROM PERITONITIS. THE OUTCOME FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION.

    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 41 YR Hospitalization| R DIANEAL UNKNOWN| DIANEAL PD4 AMBUFLEX| HOMECHOICE