BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD INFUSION SET (PRIMARY MICRO SET)

    MDR report key: 11676424 · Received April 16, 2021

    Report

    Report Number
    9616066-2021-50737
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 17, 2021
    Report Date
    June 24, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-04-01. H6: INVESTIGATION SUMMARY: ONE 7290012271014 SAMPLE WAS RECEIVED WITHOUT PACKAGING CONNECTED TO A 100ML MEDIFLEKS FLUID BAG FOR INVESTIGATION. THE CUSTOMER FEEDBACK INDICATES THE SAMPLE WAS FROM EITHER LOT 12945216 OR 12882202. THE CUSTOMER PROVIDED A PHOTOGRAPH AND VIDEO OF THE AFFECTED SAMPLE; ANALYSIS OF THE VIDEO APPEARED TO INDICATE THE PRESENCE OF AN AIR BUBBLE IMMEDIATELY PRIOR TO THE PUMPING SEGMENT FOLLOWING PRIMING OF THE SET. HOWEVER THE AIR BUBBLE DID NOT APPEAR TO MOVE THROUGH THE INFUSION LINE AND NO ALARMS OCCURRED FOLLOWING PRIMING. A VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED PART OF THE SILICONE TUBING BEFORE THE PUMP COMPONENT WAS KINKED. THE SAMPLE WAS SUBJECTED TO FUNCTIONAL TESTING BY PRIMING AND SUBJECTING TO AN INFUSION USING A BODYGUARD 323 PUMP FROM BD STOCK. THE PUMP ALARMED AIR/UP OCCLUSION IMMEDIATELY UPON STARTING THE INFUSION. NO AIR IN LINE WAS OBSERVED NEAR THE Y PORT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. THEY CONFIRMED THAT THE REPORTED AIR/UP OCCLUSION ALARMS ARE LIKELY TO HAVE OCCURRED AS A RESULT OF THE KINKED PUMPING SEGMENT, WHICH WOULD CREATE A GAP BETWEEN THE TUBING AND THE AIR SENSOR RESULTING IN THE NUISANCE ALARMS. THE KINKED PUMPING SEGMENT IS MOST LIKELY TO HAVE OCCURRED DURING BULK TRANSPORTATION OF THE PRODUCT PRIOR TO THE PACKAGING PROCESS. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 12945216 AND 12882202 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 DAMAGE OF THIS NATURE DURING FUTURE PRODUCTION, IMPROVEMENTS HAVE BEEN IDENTIFIED TO THE TRANSPORTATION PROCESS OF THE PRODUCT PRIOR TO PACKAGING. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST PRODUCTS MANUFACTURED AT THIS MANUFACTURING SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BODYGUARD INFUSION SETS (PRIMARY MICRO SETS) EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INFUSION IS STARTED, SOME AMOUNT OF AIR ACCUMULATE ON Y SIDE. DURING INFUSION, AIR IS MOVING TO PATIENT SO AIR IN LINE ALARMS HAS HAPPENED OVER AND OVER AGAIN EVEN HCP MADE PROPERLY PRIMING PROCESS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 12945216 (INVALID LOT #). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 12882202 (INVALID LOT #). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. 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 2 BODYGUARD INFUSION SETS (PRIMARY MICRO SETS) EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INFUSION IS STARTED, SOME AMOUNT OF AIR ACCUMULATE ON Y SIDE. DURING INFUSION, AIR IS MOVING TO PATIENT SO AIR IN LINE ALARMS HAS HAPPENED OVER AND OVER AGAIN EVEN HCP MADE PROPERLY PRIMING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573812 BODYGUARD INFUSION SET (PRIMARY MICRO SET) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA