BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSIII PUMP SET, 2 Y

    MDR report key: 10603001 · Received September 29, 2020

    Report

    Report Number
    9616066-2020-02880
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    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: 09/23/2020. INVESTIGATION CONCLUSION: FORTY-ONE 28034-0006 SAMPLES FROM LOT 19106853 WERE RECEIVED FOR INVESTIGATION IN SEALED PACKAGING. A VISUAL INSPECTION OF EACH OF THE RETURNED SAMPLES IDENTIFIED SOME AREAS OF KINKED AND FLATTENED TUBING IN THIRTY-SEVEN OF THE RETURNED SAMPLES. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THEY CONFIRMED THAT THE KINKED AND FLATTENED TUBING CAN BE CAUSED BY THE TUBING BEING POSITIONED OVER HARD COMPONENTS OF THE SET. DURING STERILIZATION, THE PRODUCTS ARE EXPOSED TO AN ELEVATED TEMPERATURE AND MULTIPLE VACUUM CYCLES WHICH CAN CAUSE THE PRODUCT TO BECOME PRESSED INTO THIS POSITION AND RETAIN THE KINKED SHAPE. KINKED TUBING TYPICALLY OCCURS AS A RESULT OF INADEQUATE COILING OF THE SET PRIOR TO PACKAGING AND STERILIZATION; THIS IS A MANUAL PROCESS AND IT IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19106853 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IN ORDER TO REDUCE THE LIKELIHOOD OF OPERATOR ERROR, THE PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THIS FEEDBACK AND RETRAINED TO ENSURE THAT THEY ARE FOLLOWING THE CORRECT ASSEMBLY PROCESS. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH ONE SIMILAR REPORT AGAINST THE 28034-0006 SET IN THE PAST 12 MONTHS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MSIII PUMP SET, 2 Y WAS CLOGGED/BLOCKED/OCCLUDED AND EXPERIENCED KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY HE INITIAL REPORTER: . 3 SET PRODUCT NUMBER 28034-0006 LOT 19106853 RESULT TO BE COMPRESSED IN SOME SEGMENTS AND THIS CAUSES THE STOP OF THE INFUSION AND ALARM OF THE PUMP.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MSIII PUMP SET, 2 Y WAS CLOGGED/BLOCKED/OCCLUDED AND EXPERIENCED KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY HE INITIAL REPORTER: 3 SET PRODUCT NUMBER 28034-0006 LOT 19106853 RESULT TO BE COMPRESSED IN SOME SEGMENTS AND THIS CAUSES THE STOP OF THE INFUSION AND ALARM OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066950 MSIII PUMP SET, 2 Y PUMP SET FRN SISTEMAS MEDICOS ALARIS, S.A. DE C. 19106853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200908| 20200908