BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 15715078 · Received November 2, 2022

    Report

    Report Number
    2243072-2022-01874
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    October 10, 2022
    Report Date
    February 7, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403227998
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED TUBING SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE ABOVE MALE LEUR LOCK WHEN SETTING UP PRIMARY IV TUBING WITH NORMAL SALINE WERE THERE ANY ADVERSE EVENTS? NO. D1: MEDICAL DEVICE BRAND NAME: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET. D4: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI # (B)(4). D4: CATALOG # 2426-0007. D4: MEDICAL DEVICE LOT #: 22069126. D4: MEDICAL DEVICE EXPIRATION DATE: 03-JUN-2025. H4: DEVICE MANUFACTURE DATE: 03-JUN-2022. G2: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA / 510(K)#: K944320. H6: INVESTIGATION SUMMARY. TWO SAMPLES OF MATERIAL NUMBER 2426-0007 WERE RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF TUBING DEFECTIVE/DAMAGED WAS VERIFIED BY VISUAL INSPECTION. EVALUATION OF THE SAMPLE SUBMITTED SHOWED TWO DIFFERENT TYPES OF DAMAGE TO THE INFUSION SETS. THE SAMPLE WITH LOT NUMBER 22069126 HAD A MALE LUER ADAPTER CONNECTOR THAT WAS MISSING THE SECUREMENT COLLAR AND THEREFORE COULD NOT BE SECURED TO A CORRESPONDING CONNECTION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 22069126 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 08JUN2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE FOR THE MALE LUER ADAPTER MISSING THE SECUREMENT COLLAR IS AN ISSUE WITH THE CONSTRUCTION OF THE COMPONENT. THE BODY OF THE MALE LUER ADAPTER CONNECTOR DOES NOT LOOK TO BE DAMAGED, AND IT DOES NOT APPEAR TO HAVE ANY WEAR IN THE LOCATION OF WHERE THE COLLAR WOULD BE, AND THEREFORE IT CANNOT BE CONCLUDED THAT THE INFUSION SET WAS DAMAGED DURING USE OR MISHANDLING. THE PROBABLE ROOT CAUSE FOR THE MISSING SECUREMENT COLLAR IS THAT THE COMPONENT WAS NOT ASSEMBLED CORRECTLY. THE ROOT CAUSE OF FOR THE MISSING MALE LUER ADAPTER CONNECTOR ON THE SECOND SAMPLE IS AN ISSUE WITH THE MANUFACTURING LOCATION NOT FOLLOWING THE CORRECT ASSEMBLY PROCESS. A QUALITY ALERT HAS BEEN ISSUED TO INSURE THE CORRECT AMOUNT OF SOLVENT IS APPLIED TO THE TUBING IN ORDER TO ASSURE THAT THE DISTAL MALE LUER IS ATTACHED WITH THE APPROPRIATE AMOUNT OF SOLVENT. IN ADDITION, PREVENTATIVE MAINTENANCE WILL BE PERFORMED FREQUENTLY TO ENSURE THE ASSEMBLY TOOLS ARE IN PROPER WORKING ORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS INFUSION SET EXPERIENCED TUBING SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE ABOVE MALE LEUR LOCK WHEN SETTING UP PRIMARY IV TUBING WITH NORMAL SALINE WERE THERE ANY ADVERSE EVENTS? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED TUBING SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE ABOVE MALE LEUR LOCK WHEN SETTING UP PRIMARY IV TUBING WITH NORMAL SALINE WERE THERE ANY ADVERSE EVENTS? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515760 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2426-0007 22069126 10885403227998

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown