BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 19858926 · Received July 30, 2024

    Report

    Report Number
    8010762-2024-00381
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 15, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691519876
    PMA / PMN Number
    K131666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A RESISTANCE WAS OCCURRED DURING THE INSERT OF THE PRODUCT AND THEREFORE IT IS HARD TO USE THE GUIDEWIRE. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. FURTHER, A NEW INFORMATION WAS RECEIVED FROM GETINGE SALES & SERVICE EMPLOYEE AS THE CUSTOMER DECIDED TO CANCEL THE COMPLAINT. SAMPLE INVESTIGATION COULD NOT BE PERFORMED AS THE PRODUCT WAS DISCARDED BY CUSTOMER. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED HOWEVER THE REPORTED FAILURE COULD BE LINKED TO THE RISK ASSESSMENT FILE OF PIK SETS AND THE PROBABLE CAUSE COULD BE: - USER: USER IS NOT ABLE TO SECURE THE GUIDEWIRE PROPERLY. UNINTENDED REPOSITIONING OF GUIDEWIRE IN VESSEL. - USER: USE OF GUIDEWIRE IN WRONG ORIENTATION (STRAIGHT INSTEAD OF J-TIP). - USER: USER DOES NOT RECOGNIZE OR VERIFY THE ADVANCEMENT AND POSITIONING OF THE GUIDEWIRE. INAPPROPRIATE MOVABILITY OF GUIDEWIRE IN VESSEL. - MANUFACTURING: MECHANICAL DAMAGE OF PRODUCT. - LOGISTICS: MECHANICAL DAMAGE OF PRODUCT. THESE ROOT CAUSES COULD NOT BE CONFIRMED. THE REPORTED FAILURE IS MITIGATED IN INSTRUCTION FOR USE OF THE PRODUCT AS: - IFU CAUTION! VERIFY THE ADVANCEMENT AND POSITIONING OF THE GUIDE WIRE USING APPROPRIATE IMAGING TECHNOLOGY. - IF INCREASED RESISTANCE IS FELT DURING INSERTION, PULL THE CANNULA BACK AND IDENTIFY THE CAUSE USING APPROPRIATE IMAGING TECHNOLOGY. - IFU WARNING! DAMAGE TO THE DEVICE OR PACKAGING. A NON-STERILE OR DEFECTIVE DEVICE CAN LEAD TO BLOOD LOSS OR TO EMBOLISMS OR INFECTIONS IN THE PATIENT. - PERFORM A CAREFUL VISUAL INSPECTION OF THE STERILE PACKAGING BEFORE USE. PAY PARTICULAR ATTENTION TO MOISTURE, OPENINGS AND SOILING. - PERFORM A CAREFUL VISUAL INSPECTION OF THE DEVICE BEFORE USE. IN PARTICULAR, ENSURE THERE IS NO DAMAGE TO THE MATERIAL, CRACKS, BURRS OR FRACTURES. - ONLY USE A STERILIZED DEVICE. - DO NOT USE THE DEVICE IF THE DEVICE ITSELF OR THE STERILE PACKAGING SHOW ANY SIGNS OF DAMAGE. - OBSERVE THE USE-BY DATE ON THE PACKAGING. - ADHERE TO STRICT ASEPSIS WHEN USING THE DEVICE. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED PIK 150#INSERTION KIT, GUIDEWIRE 150 CM WITH LOT# 3000287107 WAS REVIEWED ON 2024-08-12. ACCORDING TO THE DHR RESULT, THE PRODUCT PIK 150#INSERTION KIT, GUIDEWIRE 150 CM PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. FURTHER, THE INCOMING INSPECTION REPORTS OF THE AFFECTED COMPONENT 180011#FÜHRUNGSDRAHT / GUIDE WIRE (BATCH # 3000177389) WAS REVIEWED ON 2024-08-14. THE GUIDE WIRE WAS CHECKED VISUALLY FOR SHAPELESSNESS/CRIMPS ON TIP AREA. TIP AREA WAS CHECKED VISUALLY FOR OPENNESS BETWEEN WIRES. FUNCTIONAL TEST OF THE GUIDE WIRE WAS PERFORMED BY FITTING IT INSIDE TO GUIDE ADVANCER. ALSO, SIZE CHECK WAS PERFORMED FOR DEFINED PARAMETERS. ALL DEFINED PARAMETERS WERE PASSED AS PER CONTROLS. BESIDES, THE REVIEW OF THE NON-CONFORMITIES DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED PRODUCT AND FAILURE. BASED ON THE INVESTIGATION RESULTS, THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING. H3 OTHER TEXT : 4115.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RESISTANCE HAD OCCURRED DURING THE INSERT OF THE PRODUCT AND THEREFORE IT IS HARD TO USE THE GUIDEWIRE. NO HARM TO ANY PERSON WAS REPORTED. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188310 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH PIK 150#INSERTION KIT, GUIDEWIRE 150 CM 3000287107 04037691519876

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other