BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD PCA SET

    MDR report key: 12059919 · Received June 24, 2021

    Report

    Report Number
    9616066-2021-51388
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 19, 2021
    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 FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE SERIAL#: (B)(6). H.6. INVESTIGATION: ONE 7290012271069 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; RESIDUAL FLUID WAS PRESENT IN THE LINE. THE CUSTOMER FEEDBACK INDICATES THAT THE COMPLAINT SAMPLE WAS FROM LOT (B)(6). A VISUAL INSPECTION OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR MANUFACTURING ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE, SPECIFICALLY NO DAMAGE WAS NOTED TO THE PUMPING SEGMENT NOR TO THE BLACK KEY OF THE PUMPING SEGMENT. THE SAMPLE WAS SUBJECTED TO FUNCTIONAL TESTING BY PRIMING AND SUBJECTING TO AN INFUSION USING A BODYGUARD 323 PUMP FROM BD STOCK. IN EACH INSTANCE NO ALARMS WERE IDENTIFIED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT (B)(6) DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IN THIS INSTANCE AS THE INFUSION SET HAD BEEN USED FOR SEVERAL HOURS PRIOR TO THE OCCLUSION ALARMS BEING IDENTIFIED, ITS UNLIKELY THAT A MANUFACTURING DEFECT CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BODYGUARD PCA SET WAS USED AND OCCLUSION AND AIR IN LINE ALARMS WENT OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARMS WHICH ARE DOWN OCCLUSION AND AIR IN LINE ALARM HAVE OCCURRED MANY TIMES ON BG 595 PCA PUMP. ACCORDING TO OUR INVESTIGATION, CLINICAL TRAINING IS DONE, LAST USER CAN SET INFUSION APPROPRIATELY AT HOSPITAL, THEY ENSURED THAT THERE WAS NO OCCLUSION OR KINK AFTER PUMP SEGMENT. THEY DETECTED THAT SET SILICONE SEGMENT HAD BEEN CRUSHED AND THE BLACK KEY OF SETS ON THE SILICONE SIDE HAS DEFORMATION IN THE SECOND HOURS OF INFUSION, THE SET SILICONE SEGMENT STUCK TOGETHER BEFORE 48 HOURS.

    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 BODYGUARD PCA SET WAS USED AND OCCLUSION AND AIR IN LINE ALARMS WENT OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARMS WHICH ARE DOWN OCCLUSION AND AIR IN LINE ALARM HAVE OCCURRED MANY TIMES ON BG 595 PCA PUMP. ACCORDING TO OUR INVESTIGATION, CLINICAL TRAINING IS DONE, LAST USER CAN SET INFUSION APPROPRIATELY AT HOSPITAL, THEY ENSURED THAT THERE WAS NO OCCLUSION OR KINK AFTER PUMP SEGMENT. THEY DETECTED THAT SET SILICONE SEGMENT HAD BEEN CRUSHED AND THE BLACK KEY OF SETS ON THE SILICONE SIDE HAS DEFORMATION IN THE SECOND HOURS OF INFUSION, THE SET SILICONE SEGMENT STUCK TOGETHER BEFORE 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953403 BODYGUARD PCA SET INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1