BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS GP PLUS SERIES PRIMARY SET

    MDR report key: 10360258 · Received August 3, 2020

    Report

    Report Number
    9616066-2020-02405
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 13, 2020
    Report Date
    July 13, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: ALARIS¿ GP PLUS SERIES PRIMARY SET. D.4. MEDICAL DEVICE MODEL #: 63401EB. D.4. MEDICAL DEVICE CATALOG #: 63401EB. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA/510(K)#: NA. H.3. DEVICE EVALUATED BY MFG?: YES. H.3. REASON DEVICE NOT EVALUATED: OTHER. H.3. REASON DEVICE NOT EVAL: SEE H.10. H.4. DEVICE MANUFACTURE DATE: 2020-06-23. H.6. INVESTIGATION SUMMARY: ONE 63401EB SAMPLE FROM LOT 1013939 WAS RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE (B)(4).. RESIDUAL FLUID WAS PRESENT IN THE DRIP CHAMBER AND TUBING BELOW. EXAMINATION OF THE SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE AS A SECTION OF THE TUBING 200MM BELOW THE DRIP CHAMBER WAS FOUND TO BE FLATTENED AND SLICED (APPENDIX 1). EXAMINATION OF THE PACKAGING ALSO NOTED A LARGE VOID IN THE SEAL WHERE THE TUBING HAD PROTRUDED (APPENDIX 2). ROOT CAUSE ANALYSIS: THIS TYPE OF DAMAGE IS CONSISTENT WITH THAT CAUSED WHEN THE TUBING IS CAUGHT IN THE HEAT SEAL OF THE PACKAGING MACHINE. IF THE SET IS NOT COILED IN THE PACKAGING NEST CORRECTLY, THE SEAL AROUND THE EDGE OF THE PACKAGING CAN BE COMPROMISED BY THE TUBING PROTRUDING OUT OF THE PACKAGING. THE TUBING WOULD THEN BE CAUGHT IN THE PACKAGING HEAT SEAL, CAUSING THE DAMAGED AND FLATTENED APPEARANCE OF THE TUBING. THIS IS A MANUALLY PERFORMED ASSEMBLY STEP AND IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. CAZIN DHR INFO (FROM CHILD FILE): 74 PLUS INFUSION SET, 1 SS Y, MODEL 63401EB, BATCH 1013939, WAS MANUFACTURED IN SEPTEMBER 2019 IN QUANTITY OF 24000 PIECES. REVIEW OF MANUFACTURING RECORDS DID NOT FAVOR ANY QUALITY NOTIFICATION REGARDING ASSEMBLY/PACKAGING PROCESS NOR WITH THE USED COMPONENTS. THIS ISSUE TENDS TO OCCUR WITH NO SIGNIFICANT TREND RATE. MOVEMENT OF THE PRODUCT INSIDE THE BLISTER IS TO BE EXPECTED. TUBE ITSELF IS UNDER CERTAIN TENSION WHICH MAY RESULT IN POPPING OUT OF THE BLISTER BORDER WHERE IT GETS PRESSED UNDER HEAT SEAL. SEVERAL THOUSAND PRODUCTS IS PACKED PER HOUR, AND THIS ISSUE IS TO BE EXPECTED. INDIVIDUAL MOVEMENT OF THE PRODUCT AFTER COILING AND SETTING IN THE BLISTER IS SOMETHING THAT CAN NOT BE CONTROLLED. THIS ISSUE ONLY CAUSES CUSTOMER DISSATISFACTION, SINCE IT CAN NOT CAUSE ANY HEALTH HAZARD DUE TO IT'S HIGHLY NOTICEABLE FUNCTIONALITY ISSUE. INVESTIGATION CONCLUSION: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1013939 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THIS FAILURE MODE DURING FUTURE PRODUCTION. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS FOR PRODUCTS MANUFACTURED AT THIS MANUFACTURING SITE IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALARIS¿ GP PLUS SERIES PRIMARY SET WAS NOT ABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS PRODUCT NOT ALLOWING PRIMING OF FLUID. NURSE USED THE PRODUCT TO PRIME MEDICATION AS USUAL BUT FAILED TO PRIME. SHE INSPECTED THE GIVING SET AND NOTICED SQUASHED TUBING WITH TEETH-SHAPED RIP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SMARTSITE NEEDLE-FREE CONNECTOR WAS NOT ABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS PRODUCT NOT ALLOWING PRIMING OF FLUID. NURSE USED THE PRODUCT TO PRIME MEDICATION AS USUAL BUT FAILED TO PRIME. SHE INSPECTED THE GIVING SET AND NOTICED SQUASHED TUBING WITH TEETH-SHAPED RIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824582 ALARIS GP PLUS SERIES PRIMARY SET INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 63401EB 1013939

    Patients

    Seq Age Sex Outcome Treatment
    1 Other