BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 20749008 · Received November 21, 2024

    Report

    Report Number
    9616066-2024-01710
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 15, 2024
    Report Date
    January 8, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K221327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SAMPLE SEPARATED. ONE SAMPLE MODEL 2420-0007, LOT 24075317 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. THE TUBING WAS SEPARATED FROM THE SAFETY CLAMP. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED. THE CUSTOMER COMPLAINT WAS VERIFIED. A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. FROM THE MANUFACTURER'S INVESTIGATION, THE MOST POSSIBLE ROOT CAUSE THAT GENERATES A COMPONENT SEPARATION IS DUE AN INCORRECT INSERTION OF TUBING TO SOLVENT DISPENSER BY THE PRODUCTION PERSONNEL. LOT REPORTED WAS MANUFACTURED ON JUL 26, 2024, BEFORE ACTIONS STATE IMPLEMENTED FOR A SIMILAR CONDITION REPORTED. FOLLOWING ACTIONS WERE DEFINED: AN ACCESSORY TO BE IMPLEMENTED TO THE MEDICA SOLVENT DISPENSER THAT ASSISTS THE PRODUCTION PERSONNEL IN GUIDING THE TUBING TO THE INSERTION POINT. APPROVED ON (B)(6) 2024. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007, LOT NUMBER 24075317 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(6) UNITS IN 1 LOT NUMBER WAS BUILT ON 26JUL2024. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT PRIMARY TUBING TO SPIKE BAG OF GAZYVA BUT TUBING BROKE APART AS IF IT WAS NEVER ATTACHED/MADE CORRECTLY? MEDICATION LEAKED AND A NEW BAG WAS NEEDED TO BE MADE. NO HARM TO PT NOR STAFF. NEVER HAVE SEEN SUCH A MALFUNCTION WITH THE TUBING BEFORE. BREAK IN PRIMARY IV TUBING JUST BELOW THE INFUSION PUMP CLAMP.

    Description of Event or Problem · 0

    MATERIAL # 2420-0007, BATCH # 24075317. IT WAS REPORTED BY CUSTOMER THAT PRIMARY TUBING TO SPIKE BAG OF GAZYVA BUT TUBING BROKE APART AS IF IT WAS NEVER ATTACHED/MADE CORRECTLY? MEDICATION LEAKED AND A NEW BAG WAS NEEDED TO BE MADE. NO HARM TO PT NOR STAFF. NEVER HAVE SEEN SUCH A MALFUNCTION WITH THE TUBING BEFORE. BREAK IN PRIMARY IV TUBING JUST BELOW THE INFUSION PUMP CLAMP. VERBATIM: REPORTING IV TUBING CONCERN OUT OF OSHKOSH. (B)(4), DATE (B)(6) 2024, (B)(6). NO HARM TO PATIENT DID NOT REACH. PRODUCT SAVED: YES, PLEASE WORK WITH XXXXX TO SEND PRODUCT IN FOR QA TESTING. (B)(6). DESCRIPTION: USED PRIMARY TUBING TO SPIKE BAG OF GAZYVA BUT TUBING BROKE APART AS IF IT WAS NEVER ATTACHED/MADE CORRECTLY? MEDICATION LEAKED AND A NEW BAG WAS NEEDED TO BE MADE. NO HARM TO PT NOR STAFF. NEVER HAVE SEEN SUCH A MALFUNCTION WITH THE TUBING BEFORE. BREAK IN PRIMARY IV TUBING JUST BELOW THE INFUSION PUMP CLAMP. PRODUCT INFORMATION: BRAND/MANUFACTURER NAME: BD ALARIS. PRODUCT/MANUFACTURER ITEM #2420-0007. LOT / SERIAL # (B)(6). WORKDAY #1060510.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013489 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24075317 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown