BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ PUMP MODULE ADMINISTRATION SET

    MDR report key: 21653528 · Received March 20, 2025

    Report

    Report Number
    9616066-2025-00594
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 28, 2025
    Report Date
    July 10, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403490088
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    INVESTIGATION RESULT: ONE 2401-0004 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION OF (B)(4). WITH THE SAMPLE, THE CUSTOMER ALSO PROVIDED A NOTE STATING THREE LOT NUMBERS: 2404540, 24045221 (THE ORIGINALLY REPORTED LOT) AND 24045216 ALONG WITH A DATE 03 MAR 2025. SOME RESIDUAL FLUID WAS PRESENT AND NO CONNECTING PRODUCT WAS AVAILABLE TO AID THE INVESTIGATION. THE CUSTOMER REPORTED THAT "IV ALARIS LINE FAILED. CUSTOMER SAID "THE RN TOLD ME THAT IT HAPPENED LAST WEEK AS WELL AS TODAY. THE DISCONNECTION/BREAKING POINT IS DANGEROUS AS THERE IS NO VALVE AND BLOOD CAN LEAK OUT OR AIR CAN ENTER THE CANNULA. IT IS THE BD ALARIS PUMP INFUSION SET, SMARTSITE Y-SITE." VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE MALE LUER WAS SEPARATED AT THE TUBING JOINT. CLOSER INSPECTION IDENTIFIED SOME RESIDUAL ADHESIVE ON THE TUBING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. FOLLOWING AN IN-DEPTH FAILURE INVESTIGATION, THEIR ANALYSIS CONFIRMED THAT THE SEPARATION IS MOST LIKELY TO HAVE BEEN CAUSED BY THE ASSEMBLY OF AN INCORRECT MALE LUER COMPONENT ONTO THE AFFECTED INFUSION SET. THEIR ANALYSIS CONFIRMED THAT THE ISSUE IS LIKELY TO HAVE OCCURRED AS A RESULT OF AN INADEQUATE SEGREGATION OF THE COMPONENTS FOLLOWING THE MANUFACTURING PROCESS; THE SEGREGATION PROCESS IS A MANUAL PROCEDURE AND IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 2404540, 24045221 AND 2404521DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IN ORDER TO REDUCE THE LIKELIHOOD OF OPERATOR ERROR, THE PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THIS FEEDBACK TO ENSURE THAT THEY ARE FOLLOWING THE CORRECT ASSEMBLY PROCESS. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT AND WILL CONTINUE TO MONITOR THE INCOMING FEEDBACK AND REMAIN VIGILANT TO ISSUES OF THIS NATURE DURING FUTURE PRODUCTION. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE 2401-0004 SET IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE ADMINISTRATION SET SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV ALARIS LINE FAILED. THE DISCONNECTION/BREAKING POINT IS DANGEROUS AS THERE IS NO VALVE AND BLOOD CAN LEAK OUT OR AIR CAN ENTER THE CANNULA. IT IS THE BD ALARIS PUMP INFUSION SET, SMARTSITE Y-SITE. THE PRODUCT IS SET ALARIS 1 PORT 2.7MM X 2.74M, PRODUCT CODE 2401-0004. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: PLEASE CONFIRM THE LOT NUMBER(S)? 24045221. PLEASE CONFIRM WHAT IS MEANT BY "IV ALARIS LINE FAILED"? THE LINED FAILED. PLEASE CONFIRM HOW THE FAULT WAS IDENTIFIED? VISUAL CONFIRMATION OF A LEAK WHICH WAS NOT PREVIOUSLY THERE AND SHOULD NOT BE. PLEASE CONFIRM THE EXACT LOCATION OF THE REPORTED FAULT WITHIN THE SET? UNABLE TO. PLEASE CONFIRM WHAT SUBSTANCE WAS BEING INFUSED DURING THE TIME OF THE EVENT? UNABLE TO. KINDLY CONFIRM THE QUANTITY INVOLVED. 1 PLEASE CONFIRM THE INFUSION SET-UP ¿ GRAVITY OR PUMP, HEIGHT OF INFUSION LINE, ENTRY POINT TO PATIENT, INFUSION RATE AND PRESSURE, INFUSION LINE SET-UP (OTHER EXTENSIONS OR ACCESSORIES) ETC? PRIMED VIA GRAVITY, ADMINISTERED VIA PUMP. ENTRY AT IV CANNULA SITE VIA BASILIC VEIN ANTERIOR TO THE WRIST. INFUSION RATE WAS 60ML/HR. NO OTHER ACCESSORIES/EXTENSION SETS USED. PLEASE CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCT(S)? ATTACHED VIA THE MICROCLAVE CLEAR CONNECTOR PRODUCT # 011-MC100 PLEASE CONFIRM IF THERE IS ANY VISIBLE DAMAGE ON THE SET ¿ SUCH AS CRACKS, FLASHES OR DEFORMATION OF THE PISTON? THERE WAS NO VISIBLE DAMAGE TO THE SET. KINDLY CONFIRM THE PATIENT IMPACT. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212135 BD ALARIS¿ PUMP MODULE ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24045221 10885403490088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown