BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2120375 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07440
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    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 PRODUCT CODE AND LOT NUMBER OF THIS PRODUCT ARE UNKNOWN AT THIS TIME; THEREFORE THE 510K NUMBER WILL NOT BE PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE OF THE REPORTED CONDITION WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PERITONEAL DIALYSIS NURSE.THE NURSE STATED ONE OF OCCLUDER'S ON THE TWIST CLAMP OF THE TRANSFER SET WAS BROKEN. IT WAS UNKNOWN HOW LONG THE TRANSFER HAD BEEN IN PLACE. THE PATIENT CLEANS THE TRANSFER SET WITH ACLAVIS. LOT NUMBER WAS UNKNOWN. THE TRANSFER SET WAS REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF THE TRANSFER SET WAS BROKEN AND PERITONITIS WITH (B)(6) IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BROKEN TRANSFER SET. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED FOR PERITONITIS. TREATMENT PROVIDED WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. AN OUTCOME WAS NOT PROVIDED FOR THE TRANSFER SET WAS BROKEN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE TRANSFER SET WAS BROKEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization DIANEAL PD4 AMBUFLEX