BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TUBING SETS

    MDR report key: 10356189 · Received August 3, 2020

    Report

    Report Number
    9616066-2020-02260
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 9, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 08/28/2020. INVESTIGATION CONCLUSION IT WAS REPORTED THAT THE TUBING BUSTED, DURING A POSSIBLE TRANSFUSION. RECEIVED FROM THE CUSTOMER WAS ONE USED BLOOD SET MODEL 2477-0007 LOT UNKNOWN. THE SET WAS RECEIVED WITH BLOOD IN THE DRIP CHAMBER AND THE TUBING ABOVE THE DRIP CHAMBER. ALSO RECEIVED IS ONE USED MAXZERO CONNECTOR MODEL MZ1000-07 LOT UNKNOWN ATTACHED TO A 10ML BD SYRINGE LOT 0062284 EXP 2023-02-28, 0.9% SODIUM CHLORIDE INJECTION. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OBSERVED THAT THE SET WAS SEPARATED BETWEEN THE TUBING (P/N (B)(6)) AND BOTTOM OF THE BLOOD FILTER DRIP CHAMBER (P/N (B)(6)). CLOSER INSPECTION UNDER A LAB MICROSCOPE OBSERVED INSUFFICIENT SOLVENT AT THE END OF THE TUBING WHERE THE SEPARATION OCCURS. THE TUBING¿S OUTER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN MEASUREMENT SPECIFICATION OF 0.107 IN. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE SEPARATION AND THE OBVIOUS LEAKING THAT WOULD OCCUR DUE TO THE SEPARATION. EQUIPMENT USED (MEASUREMENT AND TESTING PERFORMED ON 16SEP2020) OPTICAL RAM-CNC, EQ08204, CALIBRATION DUE DATE: 5-FEB-21 DEVICE HISTORY RECORD FOR MODEL 2477-0007 COULD NOT BE PERFORMED DUE TO NO LOT NUMBER BEING PROVIDED BY CUSTOMER. THE CUSTOMER¿S REPORT OF THAT THE TUBING ¿BUSTED¿ WAS CONFIRMED TO BE A SEPARATION AT THE ENGAGEMENT BETWEEN THE TUBING AND BOTTOM OF THE BLOOD FILTER DRIP CHAMBER. THE ROOT CAUSE OF THE SEPARATION WAS IDENTIFIED AS A MANUFACTURING ISSUE FOR INSUFFICIENT SOLVENT BEING APPLIED AT THE ENGAGEMENT OF THE TUBING DUE TO EQUIPMENT AND/OR OPERATOR ERROR. MANUFACTURING IS AWARE OF SEPARATION ISSUES AT THE OBSERVED COMPONENT ENGAGEMENT IN WHICH FAILURE INVESTIGATION DIR 10000301228 WAS COMPLETED; ALONG WITH THE FOLLOWING CORRECTIVE ACTION- TRACKWISE CAPA'S 299970 REGARDING SEPARATED TUBING TO DRIP CHAMBER ENGAGEMENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIMARY TUBING SETS TUBING RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT THE TUBING BUSTED, DURING A POSSIBLE TRANSFUSION. THIS TUBING AT WC BUSTED AND EITHER HAD BLOOD IN IT FOR A TRANSFUSION OR THE PATIENT BLEED WHEN THE TUBING BROKE (FROM THE AMOUNT, I¿M GOING TO GUESS IT WAS A TRANSFUSION). TYPICALLY THEY SEND THESE TO US INTEROFFICE, BUT THIS IS TOO BLOODY TO SEND BY INTEROFFICE SAFELY.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIMARY TUBING SETS TUBING RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN . IT WAS REPORTED THAT THE TUBING BUSTED, DURING A POSSIBLE TRANSFUSION. THIS TUBING AT WC BUSTED AND EITHER HAD BLOOD IN IT FOR A TRANSFUSION OR THE PATIENT BLEED WHEN THE TUBING BROKE (FROM THE AMOUNT, I¿M GOING TO GUESS IT WAS A TRANSFUSION). TYPICALLY THEY SEND THESE TO US INTEROFFICE, BUT THIS IS TOO BLOODY TO SEND BY INTEROFFICE SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820932 PRIMARY TUBING SETS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION PRI-TUBING UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200709.| 20200709.