BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2191250 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10266
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBER (H11A22058) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE SAMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE HOME PATIENT (HP) CALLED BAXTER REGARDING A SYSTEM ERROR 2240 ALARM, THEN INDICATED THAT HOLES WERE NOTED IN THE CASSETTE TUBING FROM A CAT PLAYING WITH IT. ON (B)(6) 2011, BAXTER CONTACTED THE CAREGIVER (CG) WHO STATED THAT THE HOLES WERE CAUSED BY A KITTEN CHEWING ON THE LINE AND VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS NOTED IN THE SUPPLIES. PER THE CG, THE HP HAD BEEN ON ANTIBIOTICS PREVIOUSLY FOR AN INFECTION OF UNKNOWN ORIGIN THAT WAS NOT PERITONITIS AND THAT THE HP WAS DOING FINE. NO ALLEGATIONS WERE MADE AGAINST THE BAXTER PD PRODUCTS. ON (B)(6) 2011, BAXTER RECEIVED A CONSUMER REPORT THAT THE HP HAD CLOUDY PERITONEAL DIALYSIS (PD) EFFLUENT AND ITCHING. THE HP WAS TREATED FOR PERITONITIS. ON (B)(6) 2011, THE HP WAS ITCHING MORE THAN USUAL. CALAMINE LOTION AND BENADRYL WERE GIVEN AS TREATMENT. TREATMENT FOR THE PERITONITIS INCLUDED TAZICEF 1GM AND CEFAZOLIN 1GM, BOTH IP. THE EVENT OF CLOUDY EFFLUENT IN PD CATHETER WAS RESOLVED AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF THE EVENT OF THE INFECTION OF UNKNOWN ORIGIN HAD RESOLVED OR WAS RELATED TO THE CLOUDY EFFLUENT. THE EVENT OF ITCHING WAS ONGOING. THE REPORTER DID NOT PROVIDE A CAUSALITY STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention BENADRYL| LOCAL PD4 AMBUFLEX| LOCAL PD4 ULTRABAG| CALAMINE LOTION| HOME CHOICE