BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE CON TWISTER

    MDR report key: 1221512 · Received November 5, 2008

    Report

    Report Number
    8030665-2008-00048
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 5, 2008
    Manufacturer
    C D REYNOSA
    Product Code
    KOC
    PMA / PMN Number
    K022536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: NO INDICATION OF THE REPORTED DEFECT FOUND DURING THE DHR REVIEW. LOT MEETS ALL RELEASED CRITERIA. SAMPLE ANALYSIS: WE RECEIVED A TWISTER ASSEMBLY WITHOUT ORIGINAL PACKAGE. DURING VISUAL ANALYSIS, WE COULD DETECT A BROKEN PORT ON THE VENOUS TOP OF TWISTER. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED. CORRECTIVE ACTION: FMC REYNOSA HAS OPENED CORRECTIVE ACTION TO ADDRESS BROKEN PORTS OF THE TWISTER. THE FINDINGS OF THE INVESTIGATION COULD NOT CLEARLY ASCERTAIN THAT THE POSSIBLE EVENTS THAT LED TO THIS FAILURE. PROGRESS AND COMPLETION OF CAPA IS UNDER MANAGEMENT REVIEW CONTROL PER PROCEDURE; FMC REYNOSA WILL CONTINUE TO MONITOR OCCURRENCES AND TO IMPLEMENT CHANGES TO ELIMINATE THIS FAILURE MODE.

    Description of Event or Problem · 1

    A VERBAL REPORT FROM A USER HEMODIALYSIS FACILITY HAS BEEN RECEIVED. THE RN VERBALLY REPORTED THAT A PATIENT HAD STARTED THEIR DIALYSIS WHEN APPROX 3 MIN INTO THE TREATMENT, THE PATIENT CALLED FOR ASSISTANCE. REPORTEDLY, THE PATIENT DIDN'T FEEL WELL. WHEN THE TECHNICIAN RESPONDED, INITIALLY SHE HAD THOUGHT THAT THE BLOOD PRESSURE HAD DROPPED, WHEN SHE NOTICED BLOOD ON THE FLOOR AND BLOOD COMING FROM THE VENOUS LINE AT THE TWISTER DEVICE AREA. THE BLOOD PRESSURE AT THE TIME OF THE EVENT WAS REPORTEDLY 136/86. THE PATIENT CARE TECHNICIAN IMMEDIATELY STOPPED THE MACHINE, CLAMPED THE LINES, AND CALLED FOR FURTHER ASSISTANCE. THE RN WHO REPORTED THIS EVENT RESPONDED TO THIS INCIDENT. REPORTEDLY, SHE CAME OUT TO THE FLOOR AND EVALUATED THE PATIENT, AND THEN VISUALLY INSPECTED THE LINES AND NOTED THAT AT THE BOTTOM OF WHERE VENOUS LINE OF THE TWISTER DEVICE IS ATTACHED WAS A PARTIAL SEPARATION. THE TREATMENT WAS DISCONTINUED. THE BLOOD CONTAINED IN BOTH LINES WAS NOT RETURNED TO THIS PATIENT AND IT WAS REPORTED THAT THE TOTAL BLOOD LOSS FOR THIS EVENT WAS 400 ML. THE RN STATED ONCE THE PATIENT WAS REMOVED FROM THESE LINES, THE LINE COMPLETELY SEPARATED FROM THE TWISTER DEVICE. STAT LABS WERE ORDERED AND DRAWN. THE RESULTS OF THE HEMOGLOBIN WERE 9.8, DOWN FROM 10.5 (RESULTS FROM 2 WEEKS AGO). THE PATIENT WAS THEN RESTARTED IN ORDER TO COMPLETE THE DIALYSIS TREATMENT THAT WAS PRESCRIBED. THE TREATMENT RESUMED ON ANOTHER DIALYSIS MACHINE AND A NEW SET UP. TO DATE, THERE HAS BEEN NO FURTHER MEDICAL INTERVENTION TO THIS PATIENT AS A RESULT OF THIS EVENT. THE LINES WERE SAVED FOR EVALUATION. REPORTEDLY THIS PATIENT CONTINUES HEMODIALYSIS AS ORDERED ON AN OUTPATIENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVERSE CON TWISTER HEMODIALYSIS BLOODLINES KOC C D REYNOSA NA 8KR159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA