BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2160112 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-08988
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (H10K29039) 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.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION. THIS IS THE THIRD OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BAXTER CONTACTED THE HOME PATIENT (HP) REGARDING A PREVIOUSLY RELATED ALARM ISSUE. THE HP REPORTED THAT SHE WAS HOSPITALIZED FOR PERITONITIS ON (B)(6) 2011 AND TREATED WITH INTRAPERITONEAL (IP) ANTIBIOTICS. CULTURE RESULTS WERE UNKNOWN, BUT THE HP STATED THAT THE CLINIC WAS STILL TESTING THE PERITONEAL DIALYSIS (PD) EFFLUENT. AT THE TIME OF THIS REPORT, THE HP STATED THAT SHE WAS FINISHED WITH ANTIBIOTICS, SHE WAS IMPROVING AND WAS CONTINUING WITH PD THERAPY AT THAT TIME. THE HP BELIEVED THAT THE CAUSE OF THE PERITONITIS WAS CONSTIPATION. THE HP STATED THAT SHE TAKES UNKNOWN LAXATIVES FOR TREATMENT OF CONSTIPATION AND ON (B)(6) 2011, THE HP HAD A GOOD BOWEL MOVEMENT. SHE WAS NOT CONSTIPATED AT THE TIME OF THE REPORT. THE HP STATED THAT THE PERITONITIS CAUSED HER WEAKNESS, BUT THAT SHE WAS IMPROVING AT THE TIME OF THIS REPORT. ON (B)(6) 2011, BAXTER CONTACTED THE PDRN WHO STATED THAT SHE WASN'T AWARE IF A GRAM STAIN OR PD EFFLUENT WHITE COUNT WAS PERFORMED. SHE STATED THE EVENT OF PERITONITIS WAS RELATED TO CONSTIPATION NOT TO THE BAXTER PD PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention LOCAL (PD4) AMBUFLEX| LOCAL (PD4) ULTRABAG| HOME CHOICE