BEUDAMED
    FDA Adverse Event Summary report: N

    1423500-2010-04447

    MDR report key: 1871447 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04447
    Date Received
    October 15, 2010
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE, NO EVALUATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. AS THE SAMPLE WAS UNAVAILABLE AND LOT NUMBER UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. ROOT CAUSE FOR THE PERITONITIS AND SUBSEQUENT DEATH WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER QUALITY RELATIONS THAT A NO FLOW OCCURRED DURING A CHEMOTHERAPY INFUSION WITH THE CLEARLINK SECONDARY MEDICATION SET AND A CLEARLINK CONTINU-FLO SOLUTION SET. THE INFUSION WAS SET TO INFUSE 75ML AND THE PRIMARY WAS A KVO. THE PRIMARY SOLUTION WAS 250ML NS. THE SECONDARY SOLUTION WAS 250ML NS AND UNKNOWN CHEMOTHERAPY DRUG, IN AN UNKNOWN PLASTIC IV BAG. THE SECONDARY WAS DISCONNECTED AND RECONNECTED AND THEN FLOWED CORRECTLY. THE CHECK VALVE WAS INVERTED AND TAPPED AND THE SOLUTION BAG WAS SQUEEZED TO INITIATE FLOW. THE DRIP CHAMBER WAS NOT FULL/FLOODED AND THE NO FLOW IS OCCURRING AT THE LUER CONNECTION. THERE ARE NO SAMPLES AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A CALL FROM THE PATIENT'S FAMILY ON (B)(6)2010 REPORTING THE MALE PATIENT HAD EXPIRED. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL THERAPY. CAUSE OF DEATH AND CAUSALITY WERE NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING A FOLLOW UP CALL THE HEALTHCARE PROFESSIONAL INDICATED THE PATIENT WAS USING DIANEAL-N PD-2 1.5%. DURING A SUBSEQUENT FOLLOW UP CALL ON (B)(6)2010, THE PHYSICIAN INDICATED ON (B)(6)2004, THE PATIENT BEGAN DIANEAL-N PD-2 1.5% THERAPY. ON (B)(6)2010, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. DURING THE HOSPITALIZATION, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS ALSO DIAGNOSED WITH AN ILEUS. THE INTERVENTIONS INCLUDED: PERITONEAL RAVAGE, ADMINISTRATION OF TOBRACIN AND HEPARIN, CONTINUOUS HAEMODIAFILTRATION, AND ENDOTOXIN ADSORPTION THERAPY. ON (B)(6)2010, THE PATIENT EXPIRED OF THESE CONDITIONS AND CARDIAC FAILURE. REPORTEDLY, THE PERITONITIS LED THE FATAL EVENTS. AT THE TIME OF DEATH, PD THERAPY WAS ONGOING AND THE PERITONITIS WAS NOT RESOLVED. THE PHYSICIAN BELIEVED THAT NONE OF THE EVENTS WERE RELATED TO PD SOLUTION. THE PERITONITIS WAS POSSIBLY CAUSED BY TOUCH CONTAMINATION. THE PHYSICIAN STATED THAT THE PATIENT WAS SUSPECTED OF HAVING HAD EXTRAPYRAMIDAL SYMPTOMS (EPS) WHICH WAS NOT A CONFIRMED DIAGNOSIS. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FKX

    Patients

    Seq Age Sex Outcome Treatment
    1