BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET

    MDR report key: 18552866 · Received January 22, 2024

    Report

    Report Number
    9616066-2024-00049
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    December 15, 2023
    Report Date
    March 7, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403232341
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL# 11532269 AND LOT# 23035016 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 01MAR2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 11532269 BATCH#: 23035016 IT WAS REPORTED BY THE CUSTOMER THAT LEAKING IN AS LVP 20D LOW SORB 2SS 0.2M CV VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: (B)(4). HOSPITAL COMPLAINT REFERENCE #: (B)(4) CUSTOMER (HOSPITAL) NAME: (B)(6) HOSPITAL CUSTOMER ADDRESS: (B)(6) CONTACT NAME: (B)(6) PHONE:(B)(6) E-MAIL: (B)(6) CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: AL11532269 DESCRIPTION OF PRODUCT: SET CHECK VALVE 0.2MIC 2NF 87/6IN 2PC MALE L/L 20EA/CA LOT OR S/N: (B)(6) COMPLAINT CATEGORY: LEAKING REPORTABLE: NO INCIDENT DATE: (B)(6) 2023 HOSPITAL COMPLAINT REFERENCE #: (B)(4) DETAILS OF COMPLAINT (REPORTED ISSUE): FOR TRACKING PURPOSES PLEASE REPLY TO ALL INCLUDED ABOVE IN ANY RESPONSES. REFERENCE PIC TICKET NUMBER (B)(6) IN THE SUBJECT LINE AND ANY REPORTS RELATED TO THIS PRODUCT CONCERN. HI VENDOR REP, PLEASE FOLLOW UP WITH (B)(6) AT (B)(4) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6) 2023 HOSPITAL: (B)(6) HOSPITAL DEPARTMENT: 7CD PRODUCT: SET INFUSION 124IN LOW SORBING VMID: AL11532269 LOT NUMBER: (10)23035016 PRODUCT EXPIRY DATE: 18-DEC-2025 NUMBER OF DEFECTIVE PRODUCT(S): 1 IS SAMPLE AVAILABLE: NO CONCERN DESCRIPTION: LEAK OF CONTINUOUS CHEMO DRUG FROM THE 0.2 MICRON FILTER *CUSTOMER INDICATED THAT THEY WISH TO BE PROVIDED WITH THE FINAL RESULTS OF THIS INVESTIGATION.* COMPLAINT NOTICED: PRIOR TO USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? NO. QTY AFFECTED: 1 EA. SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA?: NO. RETURN QTY: ADDITIONAL INFO ON 04/01/2024 1. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NO SAMPLES OR PHOTOS AVAILABLE. 2. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES. 3. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO. 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PLEASE INCLUDE TREATMENT/INTERVENTION PROVIDED AND THE OUTCOME. NO REPORTED PATIENT INJURY. SET NEEDED TO BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: DESCRIPTION: LEAK OF CONTINUOUS CHEMO DRUG FROM THE 0.2 MICRON FILTER CUSTOMER INDICATED THAT THEY WISH TO BE PROVIDED WITH THE FINAL RESULTS OF THIS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602377 ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23035016 50885403232341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown