BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5390001 · Received January 25, 2016

    Report

    Report Number
    8010762-2016-00039
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    December 1, 2015
    Report Date
    March 20, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    JAN 25, 2016 10:28 AM (GMT-5:00) ADDED BY (B)(6): (B)(4). THE DEVICE HAS BEEN REQUESTED FOR RETURN; BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A VKMO AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    02/26/2016 10:48 AM (GMT-5:00) ADDED BY (B)(4): THE DEVICE HISTORY RECORD OF THE REPORTED LOT HAS BEEN REVIEWED BY MAQUET CARDIOPULMONARY MEDIKAL TEKNIK SAN.TIC.LTD.STI. WITH NO ABNORMALITY WAS FOUND. THE INVESTIGATION SHOWED THAT THE REPORTED LOT WAS A REWORK LOT. ALTHOUGH, TOTAL SET ORDER WAS (B)(4), ONLY 2 OF THEM HAD BEEN REWORKED. THE REWORK WAS RELATED TO DAMAGED BOXES. THE OUTER BOXES WERE CHANGED AND THE PRODUCTS INSIDE WERE NOT CHECKED BY MAQUET CARDIOPULMONARY MEDIKAL TEKNIK SAN.TIC.LTD. STI. IF THE OUTLET CONNECTOR WAS BROKEN DURING PRODUCTION THE DAMAGE WOULD HAVE BEEN NOTICED. THE MANUFACTURER`S REVIEW OF THE QUALITY CONTROL PROCESS INDICATED THAT A 100% FUNCTIONAL AND VISUAL INSPECTION IS CONDUCTED DURING MANUFACTURING. THE INFORMATION OBTAINED SO FAR IN THIS INVESTIGATION WOULD CONFIRM THAT THE DEVICE MET ITS SPECIFICATION AT THE TIME OF MANUFACTURING AND THEREFORE ALL DAMAGE FOUND ON THE PRODUCT ARE DUE TO EXCESSIVE OR INADEQUATE EXTERNAL PHYSICAL FORCE THAT WAS EXERTED ON THE PRODUCT AFTER THE RELEASE. THE EXACT ROOT-CAUSE WHICH LED TO THE DESCRIBED FAILURE COULD NOT BE IDENTIFIED. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE SAMPLE TO BE RETURNED WERE MADE BUT THE SAMPLE WAS NOT RECEIVED AND THEREFORE IT WAS NOT POSSIBLE FOR A FULL INVESTIGATION TO BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, BUT THE MOST PROBABLE CAUSE IS CONSIDERED TO BE DAMAGE DURING TRANSPORT. NO HEALTH RISK OR PATIENT IMPACT HAS BEEN IDENTIFIED. NO SYSTEMIC ISSUE WAS IDENTIFIED FROM THE COMPLAINT DATABASE REVIEW BUT THE DATA HOWEVER, WILL CONTINUE TO BE MONITORED AND IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME AND THE COMPLAINT WILL BE CLOSED. NOTE: THE CUSTOMER'S REPORTED ISSUE WAS REPORTED INITIALLY ON THE BASIS OF A PREVIOUS MDR (B)(4) FOR A SIMILAR ISSUE. HOWEVER, ACCORDING TO CURRENT INTERNAL PROCESSES AND EXTERNAL REGULATIONS, THE ISSUE OBSERVED BY THE CUSTOMER IN BOTH COMPLAINTS DOES NOT REPRESENT A REPORTABLE EVENT, AS THE ISSUE WAS DETECTED ON OPENING THE PACKAGING THUS EXCLUDING THE PRODUCT FROM PATIENT USE. GOING FORWARD, SUCH CASES WILL NOT BE REPORTED TO THE COMPETENT AUTHORITIES. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    WHEN CUSTOMER OPENED THE PACKAGE THEY NOTICED THAT THE BLOOD OUTLET CONNECTOR WAS BROKEN OFF. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47947 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92139022

    Patients

    Seq Age Sex Outcome Treatment
    1