BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 10722843 · Received October 22, 2020

    Report

    Report Number
    9616066-2020-20173
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 2, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/19/2020. H.6. INVESTIGATION: FOUR MP1000C-0006 SAMPLES FROM LOT 20016605 WERE RECEIVED FOR INVESTIGATION IN SEALED PACKAGING. A VISUAL INSPECTION DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MANUFACTURING ISSUES WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE SAMPLES WERE SUBJECTED TO PRESSURE TESTING IN ORDER TO REPLICATE THE CUSTOMER'S EXPERIENCE; NO LEAKAGE WAS IDENTIFIED THROUGHOUT TESTING. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 19076143 AND 20016605 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE. THE ALLEGED PRODUCT IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT RETURNED TO ASSIST THE INVESTIGATION AND TESTING OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MAXPLUS CLR POSITIVE DISPLACEMENT CONN LEAKED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GANCICLOVIR INFUSOR WAS LEAKING VIA A BD MAX PLUS CONNECTOR. DETAILED INCIDENT DESCRIPTION: PHARMACIST CONTACTED BAXTER ON 28 SEP 2020 TO REPORT 1 GANCICLOVIR INFUSOR WAS LEAKING VIA A BD MAX PLUS CONNECTOR. NO BATCH DETAILS WERE PROVIDED DURING INITIAL REPORT. CUSTOMER REPORTED LEAK ORIGIN IS THE CONNECTION BETWEEN THE INFUSOR TUBING AND BD MAX PLUS CONNECTOR. CUSTOMER REPORTED LEAK IS A CONSTANT DRIPPING. THIS HAS HAPPENED TWICE IN THE LAST WEEK. CUSTOMER REPORTED THE PATIENT IS ON BD GANCICLOVIR INFUSORS (1HOUR INFUSIONS). CUSTOMER REPORTED THEY DISCONNECTED AND FLUSHED THE PORT WITH 20MLS OF NORMAL SALINE AND NO LEAKING OCCURRED. THEY THEN RECONNECTED THE INFUSOR AND IT LEAKED AGAIN. CUSTOMER THEN CHANGED THE BD MAX PLUS CONNECTOR AND NO FURTHER LEAKING OCCURRED. FURTHER INFORMATION REQUESTED INCLUDING COMPOUNDING BATCH DETAILS, DATE THE LEAK OCCURRED, METHOD THIS EVENT WAS REPORTED, BD MAX PLUS CONNECTOR PRODUCT CODE AND BATCH DETAILS (MANUFACTURER OF CONNECTOR CAN BE NOTIFIED THEN), WHETHER ANY DAMAGE WAS OBSERVED TO THE CONNECTION PART OF DEVICE TUBING FROM THE INFUSOR, OR ON THE CONNECTION PART OF THE BD MAX PLUS CONNECTOR, WHETHER THERE WAS ANY PATIENT SKIN CONTACT WITH THE LEAKED SOLUTION AND SAMPLE AVAILABILITY. DATE OF EVENT IS REPORTED AS (B)(6) 2020 WITH THIS EVENT OCCURRING DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE ACTUAL SAMPLE HAS BEEN REQUESTED FOR INVESTIGATION, A PHOTOGRAPH HAS BEEN PROVIDED. INFORMATION WAS PROVIDED BY QA SPECIALIST ON 2 OCT 2020 CONFIRMING BD MAX PLUS CONNECTOR SAMPLES WERE PROVIDED BY CUSTOMER FOR INVESTIGATION, PRODUCT CODE MC1000P-0006, BATCH 19076143. AS CUSTOMER CONFIRMED THAT THERE WAS NO FURTHER LEAKING UPON CHANGING THE BD MAX PLUS CONNECTOR, THIS EVENT MUST HAVE BEEN CAUSED BY A FAULTY BD CONNECTOR. ACCORDINGLY NO COMPOUNDING OR DEVICE INVESTIGATION IS REQUIRED. CLARIFICATION SOUGHT REGARDING HOW MANY UNITS WERE AFFECTED AS CUSTOMER STATED THIS OCCURRED TWICE IN THE LAST WEEK AND WHETHER SAMPLE RETURNED IS THE ACTUAL OR A COMPANION SAMPLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MAXPLUS CLR POSITIVE DISPLACEMENT CONN LEAKED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GANCICLOVIR INFUSOR WAS LEAKING VIA A BD MAX PLUS CONNECTOR. DETAILED INCIDENT DESCRIPTION: PHARMACIST CONTACTED BAXTER ON 28 SEP 2020 TO REPORT 1 GANCICLOVIR INFUSOR WAS LEAKING VIA A BD MAX PLUS CONNECTOR. NO BATCH DETAILS WERE PROVIDED DURING INITIAL REPORT. CUSTOMER REPORTED LEAK ORIGIN IS THE CONNECTION BETWEEN THE INFUSOR TUBING AND BD MAX PLUS CONNECTOR. CUSTOMER REPORTED LEAK IS A CONSTANT DRIPPING. THIS HAS HAPPENED TWICE IN THE LAST WEEK. CUSTOMER REPORTED THE PATIENT IS ON BD GANCICLOVIR INFUSORS (1 HOUR INFUSIONS). CUSTOMER REPORTED THEY DISCONNECTED AND FLUSHED THE PORT WITH 20MLS OF NORMAL SALINE AND NO LEAKING OCCURRED. THEY THEN RECONNECTED THE INFUSOR AND IT LEAKED AGAIN. CUSTOMER THEN CHANGED THE BD MAX PLUS CONNECTOR AND NO FURTHER LEAKING OCCURRED. FURTHER INFORMATION REQUESTED INCLUDING COMPOUNDING BATCH DETAILS, DATE THE LEAK OCCURRED, METHOD THIS EVENT WAS REPORTED, BD MAX PLUS CONNECTOR PRODUCT CODE AND BATCH DETAILS (MANUFACTURER OF CONNECTOR CAN BE NOTIFIED THEN), WHETHER ANY DAMAGE WAS OBSERVED TO THE CONNECTION PART OF DEVICE TUBING FROM THE INFUSOR, OR ON THE CONNECTION PART OF THE BD MAX PLUS CONNECTOR, WHETHER THERE WAS ANY PATIENT SKIN CONTACT WITH THE LEAKED SOLUTION AND SAMPLE AVAILABILITY. DATE OF EVENT IS REPORTED AS (B)(6) 2020 WITH THIS EVENT OCCURRING DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE ACTUAL SAMPLE HAS BEEN REQUESTED FOR INVESTIGATION, A PHOTOGRAPH HAS BEEN PROVIDED. INFORMATION WAS PROVIDED BY QA SPECIALIST ON 2 OCT 2020 CONFIRMING BD MAX PLUS CONNECTOR SAMPLES WERE PROVIDED BY CUSTOMER FOR INVESTIGATION, PRODUCT CODE: (B)(4), BATCH 19076143. AS CUSTOMER CONFIRMED THAT THERE WAS NO FURTHER LEAKING UPON CHANGING THE BD MAX PLUS CONNECTOR, THIS EVENT MUST HAVE BEEN CAUSED BY A FAULTY BD CONNECTOR. ACCORDINGLY NO COMPOUNDING OR DEVICE INVESTIGATION IS REQUIRED. CLARIFICATION SOUGHT REGARDING HOW MANY UNITS WERE AFFECTED AS CUSTOMER STATED THIS OCCURRED TWICE IN THE LAST WEEK AND WHETHER SAMPLE RETURNED IS THE ACTUAL OR A COMPANION SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188237 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 19076143

    Patients

    Seq Age Sex Outcome Treatment
    1