BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243359 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12059
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K923065
    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 EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE LOT NUMBER IS UNKNOWN; THEREFORE, BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (H11E31019 AND H11E25078) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. A TREND REVIEW WAS CONDUCTED AND SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    DURING A CALL TO THE BAXTER TECHNICAL SERVICE REPRESENTATIVE REGARDING AN UNRELATED ISSUE, THE CAREGIVER INDICATED THE PATIENT HAD BEEN HOSPITALIZED AND IN REHAB DUE TO A DIAGNOSIS OF PERITONITIS. DURING A FOLLOW UP CALL TO THE FACILITY NURSE ON (B)(6) 2011 THE FOLLOWING INFORMATION WAS RECEIVED: THE PATIENT DID EXPERIENCE PERITONITIS. HE WAS HOSPITALIZED FROM (B)(6) 2011 AT A HOSPITAL NOT AFFILIATED WITH THE (B)(6) AGENCY. THE PATIENT DID RECEIVE ANTIBIOTICS BUT PRODUCT, DOSE, ROUTE AND LENGTH OF THERAPY ARE UNKNOWN. THE PERITONEAL DIALYSIS FACILITY DID NOT RECEIVE INFORMATION RELATED TO THE EVENT OF PERITONITIS. REPORTEDLY, WHEN THE PATIENT WAS DISCHARGED FROM THE HOSPITAL HE WENT TO AN UNKNOWN REHAB FACILITY FOR AN UNKNOWN LENGTH OF TIME. THE PATIENT REPORTEDLY WAS DISCHARGED TO HOME FROM THE REHAB FACILITY ON AN UNKNOWN DATE. THE PATIENT IS CURRENTLY UNDER THE CARE OF AN UNKNOWN HOME HEALTH AGENCY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 1.5% LO/CAL UB 2L/2L DIANEAL| DIANEAL LOW CA 1.5 6L/6L| DIANEAL LOW CA 4.25 6L/6L| 2.5% LO/CAL UB 2L/2L DIANEAL| DIANEAL LOW CA 2.5 6L/6L| HOMECHOICE| 4.25% LO/CAL UB 2L/2L DIANEAL