BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 20169761 · Received September 9, 2024

    Report

    Report Number
    9616066-2024-01265
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 6, 2024
    Report Date
    December 18, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403232329
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE CUSTOMER REPORTED LEAKAGE AND RETURNED ONE USED SAMPLE OF MATERIAL 2432-0007, BATCH 24055586. UPON INITIAL VISUAL EXAMINATION, THE SMART SITE DESCRIBED BY CUSTOMER, ABOVE THE FILTER, WAS FOUND TO HAVE GREEN MEDICATION AROUND IT. THE LEAKAGE WAS VERIFIED. THE SMART SITE WAS EXAMINED FURTHER UNDER A MICROSCOPE, AND THE LEAKAGE CAUSE COULD NOT BE IDENTIFIED. THE SMART SITE WAS SENT TO THE MANUFACTURING SITE FOR FURTHER ANALYSIS. THE MANUFACTURING SITE TOOK APART THE SMART SITE AND FOUND THE BLUE PISTON INSIDE TO HAVE A CUT ACROSS IT. THE PISTON IN QUESTION IS PRODUCED AT ANOTHER BD LOCATION, NAMC, WHO WAS THEN FORWARDED THE SAMPLE. NAMC COULD NOT IDENTIFY A ROOT CAUSE FOR THE CUT IN THE PISTON, AND FOUND IT TO BE THE ONLY COMPLAINT OR ISSUE OF THIS TYPE IN THE LAST YEAR, AND OVER 1 MILLION PARTS PRODUCED. THE INVESTIGATION FOUND ALL APPLICABLE PROCEDURES AND QUALITY CHECKS TO BE IN NORMAL CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET LEAKS. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: DESCRIBE THE EVENT OR PROBLEM (PLEASE PROVIDE AS MUCH DETAIL AS POSSIBLE): THE FAMILY REPORTED POSSIBLE LEAKING FROM IV TUBING. THIS RN AND MORGAN NAPIER RN CHECKED IV TUBING FOR LEAKS. DISCOVERED LEAK AT IV PORT ABOVE FILTER ON TPN TUBING. PORT WAS COVERED WITH A CUROS CAP. WHEN CUROS CAP WAS REMOVED TPN WAS LEAKING THROUGH THE PORT. TPN WAS STOPPED. TUBING WAS DISCONNECTED AND MD WAS NOTIFIED.

    Description of Event or Problem · 0

    MATERIAL #: 2432-0007 BATCH#: 24055586. IT WAS REPORTED BY CUSTOMER THAT THE FAMILY REPORTED POSSIBLE LEAKING FROM IV TUBING. THIS RN AND MORGAN NAPIER RN CHECKED IV TUBING FOR LEAKS. DISCOVERED LEAK AT IV PORT ABOVE FILTER ON TPN TUBING. PORT WAS COVERED WITH A CUROS CAP. WHEN CUROS CAP WAS REMOVED TPN WAS LEAKING THROUGH THE PORT. TPN WAS STOPPED. TUBING WAS DISCONNECTED AND MD WAS NOTIFIED. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. DESCRIBE THE EVENT OR PROBLEM (PLEASE PROVIDE AS MUCH DETAIL AS POSSIBLE): THE FAMILY REPORTED POSSIBLE LEAKING FROM IV TUBING. THIS RN AND MORGAN NAPIER RN CHECKED IV TUBING FOR LEAKS. DISCOVERED LEAK AT IV PORT ABOVE FILTER ON TPN TUBING. PORT WAS COVERED WITH A CUROS CAP. WHEN CUROS CAP WAS REMOVED TPN WAS LEAKING THROUGH THE PORT. TPN WAS STOPPED. TUBING WAS DISCONNECTED AND MD WAS NOTIFIED. ITEM -2432-0007. LOT -24055586.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537476 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24055586 10885403232329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown