BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETERS & CANNULAE

    MDR report key: 9139844 · Received October 1, 2019

    Report

    Report Number
    8010762-2019-00313
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 6, 2019
    Report Date
    January 21, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH REQUESTED THE PRODUCT BACK FOR LABORATORY INVESTIGATION. DURING THE OPTICAL EXAMINATION OF THE CATHETER, A CABLE TIE THAT WAS NOT INSTALLED BY MAQUET WAS FOUND AT THE CONNECTION POINT TO THE 1 / 2X1 / 2 CONNECTOR. GETINGE CP ANTALYA HAS ALSO INVESTIGATED THE COMPLAINT. ACCORDING TO THE BOP 9200428, THE CATHETERS ARE MOUNTED ON THE CONNECTORS WITH HELP OF COMPRESSED AIR. ALL SEMI-FINISHED PRODUCTS NEED A MINIMUM PRESSURE OF 6 BARS FOR PROPER ASSEMBLING. IN ADDITION, NO DAMAGE HAS BEEN REPORTED BY THE CUSTOMER PRIOR TO USE. THE CUSTOMER DISCONNECTED THE CATHETER FROM THE CONNECTOR AFTER THE TREATMENT WAS COMPLETED AND, DUE TO UNSTABLE HEMODYNAMICS IN THE PATIENT, TRIED TO CONNECT THE TUBE TO THE CONNECTOR AGAIN.WHILE THE CUSTOMER WAS RECONNECTING, IT MAY NOT HAVE BEEN PROPERLY INSTALLED IN THE ASSEMBLY. IT IS THE RESPONSIBILITY OF THE CUSTOMER TO SECURE THE RECONNECTION. BASED ON THIS, THE FAILURE COULD NOT BE CONFIRMED. TREND SEARCH HAS BEEN PERFOMED. NO ADDITIONAL COMPLAINT WAS FOUND FOR THE LAST 12 MONTHS.OCCURRENCE RATE: 0,4%.DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. DHR WAS REVIEWED.THERE ARE NO EVIDENCES INDICATING A NON CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING THE MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE REPORTED FAILURE WAS IDENTIFIED AS PART OF THE CURRENT RISK MANAGEMENT FILE (DMS#1533358 V15) AND THE MOST POSSIBLE ROOT CAUSE IS ASSOCIATED TO LACK OF ATTENTION OF USER. MITIGATIONS FOR THIS SPECIFIC FAILURE ARE IN PLACE IN INSTRUCTION FOR USE AND PROCESS RISK ASSESSMENT DOCUMENTS. IFU: USER ERROR:LACK OF ATTENTION. HANDLING OF THE DEVICE MAY RESULT IN DAMAGE AND LEAKS, WHICH CAN LEAD TO INFECTIONS, BLOOD LOSS, AND EMBOLISMS IN THE PATIENT. DO NOT USE THE DEVICE IF THERE ARE ANY LEAKS. AVOID DAMAGING THE DEVICE. SECURE AND SUTURE THE CATHETER CAREFULLY. PRA: 100% CONTROLS OF DAMAGE OF THE INSERTED PARTS DURING MANUFACTURING. THE REPORTED FAILURE DID NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. NO ACTION IN THE FIELD ARE REQUIRED. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY GMBH AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT: #(B)(4).

    Description of Event or Problem · 1

    CUSTOMER FINISH CPB, DISCONNECTED TUBING FROM CANNULAE......DUE TO UNSTABLE HEMODYNAMIC OF PATIENT.....RECONNECTED TUBING WITH CANNULAE AND START CPB......DURING RECONNECTED - CONNECTOR OF CANNULAE FELL - CUSTOMER USED STRAPPING TAPE. COMPLAINT NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933589 CATHETERS & CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH VENOUS - TWO-STAGE 92210764

    Patients

    Seq Age Sex Outcome Treatment
    1