BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1860810 · Received October 7, 2010

    Report

    Report Number
    1423500-2010-04122
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS OPENED TO ADDRESS A PATIENT REACTION OF PERITONITIS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO THE PATIENT'S MEDICAL CONDITION, AS IDENTIFIED BY THE PATIENT'S NURSE IN THE COMPLAINT FILE. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND THERE IS NO ALLEGATION OF A SPECIFIC PRODUCT FAILURE CAUSING THE PERITONITIS, NO PRODUCT CAUSES FOR THE PERITONITIS ARE IDENTIFIED. A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS (H10E23017), WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERFORATED BOWEL AND UNSPECIFIED PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT DEVELOPED A "PERFORATED BOWEL CAUSING PERITONITIS." ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE PERFORATED BOWEL AND UNSPECIFIED PERITONITIS. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. THE PATIENT HAD NOT RECOVERED FROM THE EVENTS.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "VERTEBROPLASTY AND KYPHOPLASTY UNDER LOCAL ANESTHESIA: REVIEW OF 91 PATIENTS", THE FOLLOWING WAS REPORTED: ONE PATIENT WHERE CEMENT LEAKAGE WAS OBSERVED INTO THE EPIDURAL SPACE. THIS PATIENT IMMEDIATELY UNDERWENT AN OPEN OPERATION AND DECOMPRESSION AND STABILIZATION WERE PERFORMED. DURING THE FOLLOW-UP PERIOD, WE DETERMINED 12 NEW ADJACENT VERTEBRAE FRACTURES (10.7%). NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG