BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 7709053 · Received July 21, 2018

    Report

    Report Number
    2937457-2018-02058
    Event Type
    Malfunction
    Date Received
    July 21, 2018
    Date of Event
    July 6, 2018
    Report Date
    September 11, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KOC
    PMA / PMN Number
    K141281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: CORRECTED CATALOG #, LOT #, AND UDI #. PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    PMA/510(K)# TO K141281.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPDATED PMA/510(K)# TO K152953.

    Description of Event or Problem · 1

    A USER FACILITY NURSE REPORTED A BLOOD LEAK THAT OCCURRED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED ON THE CIRCULAR SECTION OF THE CLIC BLOOD CHAMBER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 120ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS MOVED TO ANOTHER MACHINE AND COMPLETED TREATMENT WITH NO HARM, ADVERSE EVENTS, OR MEDICAL INTERVENTION. ADDITIONAL PATIENT AND DEVICE INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE DEVICE WAS REPORTED TO HAVE BEEN RETURNED BACK TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551234 CRIT-LINE BLOOD CHAMBER ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS KOC CONCORD MANUFACTURING 18BRO1017

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR