BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET

    MDR report key: 16549875 · Received March 15, 2023

    Report

    Report Number
    2243072-2023-00395
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 16, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BLOOD BACKED INTO THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET LINE DURING THE INFUSION, OCCLUDING IT DURING THE FLUSH. THIS RESULTED IN MEDICAL INTERVENTION; THE PICC LINE HAD TO BE REPLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTICED BLOOD IN PICC LINE CATHETER AND PUMP READING OCCLUSION. PICC LINE WOULD NOT FLUSH... NEONATAL PICC LINE CLOTTED OFF." D1: MEDICAL DEVICE BRAND NAME: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET D2: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI #:(B)(4). D4: MEDICAL DEVICE CATALOG #: 2420-0007. G2: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA / 510(K)#: K944320. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 02-JUN-2023. INVESTIGATION SUMMARY: ONE SAMPLE MODEL 2420-0007 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED WITH WATER AND ALLOWED TO FLOW. NO LEAKAGE WAS OBSERVED. THE CUSTOMER COMPLAINT THAT THERE WAS LEAKAGE COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DHR WAS PERFORMED FOR THE POSSIBLE LOTS: A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22115425 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 18NOV2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22115468 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 18NOV2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22115498 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 18NOV2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD BACKED INTO THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET LINE DURING THE INFUSION, OCCLUDING IT DURING THE FLUSH. THIS RESULTED IN MEDICAL INTERVENTION; THE PICC LINE HAD TO BE REPLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTICED BLOOD IN PICC LINE CATHETER AND PUMP READING OCCLUSION. PICC LINE WOULD NOT FLUSH... NEONATAL PICC LINE CLOTTED OFF."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD BACKED INTO THE UNSPECIFIED BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET PICC LINE DURING THE INFUSION, OCCLUDING IT DURING THE FLUSH. THIS RESULTED IN MEDICAL INTERVENTION; THE PICC LINE HAD TO BE REPLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTICED BLOOD IN PICC LINE CATHETER AND PUMP READING OCCLUSION. PICC LINE WOULD NOT FLUSH... NEONATAL PICC LINE CLOTTED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143235 BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET 2420-0007 FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2420-0007 UNKNOWN 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention