BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 1062300 · Received June 18, 2008

    Report

    Report Number
    8030665-2008-00033
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 18, 2008
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY LOT REVIEW: NO INDICATION OF THE REPORTED DEFECT WAS FOUND DURING THE DHR REVIEW. LOT MEETS ALL RELEASED CRITERIA. SAMPLE ANALYSIS: WE RECEIVED A ARTERIAL LINE WITHOUT THE ORIGINAL PACKAGING. DURING VISUAL ANALYSIS, WE COULD DETECT A SEPARATION AT SALINE TUBING TO "T" CONNECTOR. NO SOLVENT ON TUBING. CONCLUSION: THE COMPLAINT IS CONFIRMED, CORRECTIVE ACTION: THE ROOT CAUSE COULD BE ATTRIBUTED TO INSUFFICIENT AMOUNT OF SOLVENT USED DURING THE BONDING OPERATION. FMC REYNOSA HAS DESIGNATED RESOURCES, STANDARDIZING THE BUSHING FROM 1/4 TO 3/8 INCH. DESCRIPTION OF THE CHANGE FOR THIS NEW CONFIGURATION IS DOCUMENTED. FMC REYNOSA WILL CONTINUE TO MONITOR OCCURRENCES, AND TO IMPLEMENT CHANGES IN ORDER TO ELIMINATE THIS FAILURE MODE.

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT WAS RECEIVED FROM A HEMODIALYSIS USER FACILITY. THE FACILITY HAS REPORTED THAT THE SALINE LINE SEPARATED FROM THE BLOOD TUBING AFTER THE TREATMENT HAD STARTED. THE FACILITY HAS BEEN CONTACTED WHERE IT HAS BEEN LEARNED THAT AT THE START OF DIALYSIS, THE SALINE LINE SEPARATED FROM THE ARTERIAL LINE. THE LINE WAS CLAMPED RIGHT AWAY. THE RN REPORTED NO BLOOD LOSS. ONCE THE EVENT WAS DETECTED, A NEW ARTERIAL LINE WAS SET UP ON THE DIALYSIS MACHINE AND THE PRESCRIBED TREATMENT WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENCE. THERE IS NO REPORT OF INJURY OR ILL EFFECT. A SAMPLE HAS BEEN SAVED FOR AN EVAL. THE PT WAS DISCHARGED TO HOME WHEN THE TREATMENT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 7LR073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA