BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS CANNULAE & PIK

    MDR report key: 19181827 · Received April 25, 2024

    Report

    Report Number
    3008355164-2024-00014
    Event Type
    Death
    Date Received
    April 25, 2024
    Report Date
    June 27, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : 4115.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION WAS OBTAINED BY GETINGE SALES & SERVICE REPRESENTATIVE WHIIE GATHERING INFORMATION FOR COMPLAINT MCP REF. 1016449 (MFG REPORT NUMBER 8010762-2024-00184). THE REPORTED FAILURE WAS OCCURRED ON THE SAME PATIENT AND DURING THE SAME EVENT WITH COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). IT WAS REPORTED THAT A BLOOD VESSEL WAS LACERATED WHEN A HLS CANNULAE INSERTED. THE CAUSE OF THE DAMAGE WAS REPORTED AS CANNULATION PROCEDURE COMPLICATIONS BY CUSTOMER. PATIENT EXPIRED DURING TREATMENT. MORE INFORMATION WAS REQUESTED FROM CUSTOMER TO EVALUATE THE FAILURE CLEARLY HOWEVER IT WAS CONFIRMED THAT THE FAILURE IS RELATED WITH USER FAILURE AND MORE INFORMATION WILL NOT BE PROVIDED. THE SAMPLE INVESTIGATION COULD NOT BE PERFORMED SINCE THE PRODUCT WAS DISCARDED BY CUSTOMER. HOWEVER, CUSTOMER REPORTED A SERIOUS INJURY / DEATH WITHIN THE COMPLAINT. BASED ON THIS, COMPLAINT COULD BE CONFIRMED BUT PRODUCT FAILURE COULD NOT BE CONFIRMED. THE LOT NUMBER OF THE PRODUCT COULD NOT BE PROVIDED BY CUSTOMER. THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. FURTHER, THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED COMPONENTS WITH RELATED TO THE REPORTED FAILURE. GETINGE MEDICAL AFFAIRS CONDUCTED A MEDICAL REVIEW. THE REPORTED FAILURE WAS DESCRIBED AS: THE COMPLAINT NARRATIVE THAT PERTAINS TO BOTH COMPLAINT #(B)(4) DETAIL AN INCIDENT WHERE THE GUIDEWIRE USED FOR CANNULA INSERTION BECAME KINKED UPON ENTRY INTO THE BODY. ADDITIONALLY, IT IS NOTED THAT RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE GUIDEWIRE, WHICH WAS FOUND TO BE BROKEN BEFORE THE CANNULA WAS INSERTED. WHILE INSERTION OF THE CANNULA THE AFFECTED BLOOD VESSEL WAS TORN. THE FACILITY REPORTED THAT COMPLICATIONS FROM THE CANNULATION PROCEDURE, A VESSEL LACERATION DURING CANNULA INSERTION, WERE RESPONSIBLE FOR THE PATIENT'S DETERIORATION, AND THEREFORE, THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE BROKEN GUIDEWIRE AND THE DEMISE OF THE PATIENT. AS A CONCLUSION OF MEDICAL REVIEW: A DEFINITIVE CAUSE OF THE INCIDENT CANNOT BE PROPERLY EVALUATED WITHOUT FURTHER INFORMATION OR THE PRESENCE OF THE SUSPECTED/REPORTED GUIDEWIRE. THE VESSEL TORN/LACERATION DURING THE PLACEMENT OF CANNULA WAS REPORTED BY CUSTOMER WHICH MIGHT HAVE CAUSED TO PATIENT¿S EXPIRATION. SINCE THE GUIDEWIRE BECAME KINKED, WAS STUCK, AND BROKEN DURING PLACEMENT, THE DAMAGE OF THE VESSEL COULD BE CAUSED BY A PLACEMENT TECHNIQUE OR PRE-EXISTING CONDITIONS OF THE VESSEL. THE RELATED MITIGATIONS ARE IN PLACE ACCORDING TO THE INSTRUCTION FOR USE OF THE PRODUCT (PIK) AS FOLLOW: 4 CONTRAINDICATIONS THE DEVICE MUST NOT BE USED IN THE FOLLOWING CONDITIONS: KNOWN DISSECTION OF THE TARGET VESSEL. SEVERE PERIPHERAL VASCULAR DISEASE, INCLUDING SEVERE VESSEL CALCIFICATION. PRESENCE OF VASCULAR GRAFTS OR AN INTRAVASCULAR STENT AT THE INTENDED CANNULATION SIZE. KNOWN MISMATCH BETWEEN VESSEL DIAMETER AND INTENDED CANNULA SIZE. KNOWN PARTIAL OR TOTAL OCCLUSION OF THE TARGET VESSEL. H3 OTHER TEXT : 4115.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS OBTAINED BY GETINGE SALES & SERVICE REPRESENTATIVE WHIIE GATHERING INFORMATION FOR COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). THE REPORTED FAILURE HAD OCCURRED ON THE SAME PATIENT AND DURING THE SAME EVENT WITH COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). IT WAS REPORTED THAT A BLOOD VESSEL WAS LACERATED WHEN A HLS CANNULAE WAS INSERTED. THE CAUSE OF THE DAMAGE WAS REPORTED AS CANNULATION PROCEDURE COMPLICATIONS BY CUSTOMER. PATIENT EXPIRED DURING TREATMENT. COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160935 HLS CANNULAE & PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death