BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2120370 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07438
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 IS CURRENTLY UNKNOWN; THEREFORE, A 510K NUMBER WILL NOT BE PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE FOR CLARIFICATION OF THE REPORTED PROBLEM DISCONNECTING FROM THE DEVICE. THE NURSE REPORTED THAT THE PROBLEM WAS NOT WITH THE DEVICE ITSELF, BUT THAT THE PATIENT DID NOT FOLLOW INSTRUCTIONS AND DID NOT WAIT FOR THE NURSE TO DISCONNECT HIM FROM THE DEVICE. THE PATIENT IS IN A NURSING HOME AND THE NURSES ARE RESPONSIBLE FOR STARTING AND ENDING THERAPY. SHE ALSO VERBALIZED THAT WHEN THE PATIENT DISCONNECTED FROM THERAPY, HE DISCONNECTED THE TRANSFER SET AND CONTAMINATED THE CATHETER. SHE REPORTED THAT THE PATIENT HAS BEEN RE-EDUCATED ON WAITING FOR THE NURSE TO DISCONNECT HIM. NO FURTHER INFORMATION WAS AVAILABLE. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBER (H10L17040) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBER (H10K17083) REVEALED AN EXCEPTION RELATED TO EMBEDDED PARTICULATE MATTER. THERE IS NO EVIDENCE TO SUPPORT ASSOCIATION TO THE REPORTED PROBLEM. THE AFFECTED PRODUCT WAS 100% INSPECTED. CORRECTIVE ACTIONS IMPLEMENTED AND EFFECTIVE. QUALITY INSPECTIONS WERE ACCEPTABLE WITH ALL PRODUCT RELEASE REQUIREMENTS ACCEPTABLE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH TIER I CAPA (B)(4).

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS NURSE REPORT FROM (B)(6) OF PATIENT MADE MISTAKE / TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX AND EXTRANEAL VIAFLEX (DOSAGES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE STATED THAT ON AN UNREPORTED DATE, THE PATIENT MADE MISTAKE / TOUCH CONTAMINATION AND HAD PROBLEMS REMOVING HIMSELF FROM THE MACHINE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THAT SAME DAY. THE NURSE STATED THAT THE CAUSE OF THE PERITONITIS WAS THAT THE PATIENT MADE MISTAKE/ TOUCH CONTAMINATION. TREATMENT INFORMATION WAS NOT REPORTED. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECOVERED FROM THE PERITONITIS. THE OUTCOME FOR THE EVENT OF PATIENT MADE MISTAKE / TOUCH CONTAMINATION WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT REPORTED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization DIANEAL PD2 AMBUFLEX| EXTRANEAL VIAFLEX