BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSET NON DEHP, 1,2 FILTER,PRIMING

    MDR report key: 10694497 · Received October 17, 2020

    Report

    Report Number
    9616066-2020-20081
    Event Type
    Malfunction
    Date Received
    October 17, 2020
    Date of Event
    September 21, 2020
    Report Date
    November 2, 2020
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LISTED IS NOT A FINISHED MEDICAL DEVICE BY BD AND THEREFORE SHOULD NOT HAVE BEEN REPORTED. MFR#: 9616066-2020-20081 IS CANCELLED AND VOID AS A RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MICROSET NON DEHP, 1,2 FILTER,PRIMING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS CURRENTLY IN HOSPITAL AND HAS RANG TO REPORT THEIR GIVING SET IS LEAKING. PATIENT HAS BEEN ADVISED TO STOP THE PUMP AND CLAMP THE LINE. ONE OF THE HOSPITAL NURSES HAS DISCONNECTED THE LINE. PATIENT DID NOT REPORT HOW LONG INTO THE INFUSION THIS OCCURRED OR WHERE THE LEAKAGE WAS LOCATED. PATIENT USES A BODYGUARD 323 PUMP, UNKNOWN SN. PATIENT¿S PN IS REFRIGERATED HOWEVER ALLOWED TO COME TO ROOM TEMPERATURE BEFORE INFUSION. NO ISSUES REPORTED WITH PRIMING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 12871220 AND 12871216. THESE DO NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: A 120-112XSFVK PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 12871220 OR 12871216. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE EXACT LOCATION OF THE LEAKAGE. DHR REVIEW PERFORMED AND NO RELATED NON-CONFORMITIES OBSERVED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 12871220 AND 12871216 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. INVESTIGATION CONCLUSION: IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. RATIONALE: CME ARE THE LEGAL MANUFACTURER OF THIS DEVICE AND HAVE THE RESPONSIBILITY FOR ASSESSING THE CLINICAL RISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MICROSET NON DEHP, 1,2 FILTER,PRIMING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS CURRENTLY IN HOSPITAL AND HAS RANG TO REPORT THEIR GIVING SET IS LEAKING. PATIENT HAS BEEN ADVISED TO STOP THE PUMP AND CLAMP THE LINE. ONE OF THE HOSPITAL NURSES HAS DISCONNECTED THE LINE. PATIENT DID NOT REPORT HOW LONG INTO THE INFUSION THIS OCCURRED OR WHERE THE LEAKAGE WAS LOCATED. PATIENT USES A BODYGUARD 323 PUMP, UNKNOWN SN. PATIENT¿S PN IS REFRIGERATED HOWEVER ALLOWED TO COME TO ROOM TEMPERATURE BEFORE INFUSION. NO ISSUES REPORTED WITH PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159211 MICROSET NON DEHP, 1,2 FILTER,PRIMING INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other