BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2072957 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05204
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE THIRD OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4) - A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS GD883108 AND GD881557 WITH DEFECTS NO DEFECTS NOTED. ROOT CAUSE HAS BEEN DETERMINED AS USER ERROR- POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF USER ERROR- POOR ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE HOMEPATIENT (HP) TOLD BAXTER DURING A FOLLOW UP CALL REGARDING AN UNRELATED ISSUE THAT HE HAD ABDOMINAL PAIN, VOMITING AND CLOUDY PERITONEAL EFFLUENT (PD) ON (B)(6) 2011. THE HP CALLED HIS PERITONEAL DIALYSIS NURSE (PDRN) WHO INSTRUCTED HIM TO COME TO THE DIALYSIS CLINIC. THE HP BEGAN TREATMENT FOR PERITONITIS THAT DAY. HE WAS TREATED WITH GENTAMICIN INTRAPERITONEALLY (IP) FOR 4 DOSES WITH CIPROFLOXACIN 250MG ORALLY TWICE DAILY FOR 30 DAYS. THE HP STATED THAT THE PD EFFLUENT WAS CLEAR AT THE TIME OF THIS REPORT. A FOLLOW UP APPOINTMENT IS SCHEDULED AT THE PD CLINIC ON (B)(6) 2011. BAXTER ALSO THEN CONTACTED THE PDRN WHO GAVE CAUSALITY AS THE PRESENCE OF THE HP'S DOG AND DANDER IN THE AIR DURING PD THERAPY. THE PDRN STATED, "THE HP ISN'T THE BEST HOUSEKEEPER AND THAT THE EVENT COULD HAVE BEEN PET RELATED. THAT'S ALL I AM GOING TO SAY."

    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 51 YR Required Intervention LOWCAL(PD4 ULTRABAG| HOME CHOICE CYCLER| LOWCAL(PD4) AMBUFLEX| EXTRANEAL