BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN 3000

    MDR report key: 18117404 · Received November 12, 2023

    Report

    Report Number
    3015537318-2023-00043
    Event Type
    Injury
    Date Received
    November 12, 2023
    Report Date
    November 12, 2023
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    UDI-DI
    10886704043591
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILE.

    Description of Event or Problem · 0

    LITERATURE REPORT: VERHEIJ FS, KUHLMANN KFD, SILLIMAN DR, SOARES KC, KINGHAM TP, BALACHANDRAN VP, DREBIN JA, WEI AC, JARNAGIN WR, CERCEK A, KOK NFM, KEMENY NE, D'ANGELICA MI. COMBINED HEPATIC ARTERIAL INFUSION PUMP AND SYSTEMIC CHEMOTHERAPY IN THE MODERN ERA FOR CHEMOTHERAPY-NAIVE PATIENTS WITH UNRESECTABLE COLORECTAL LIVER METASTASES. ANN SURG ONCOL. 2023 AUG 28. DOI: 10.1245/S10434-023-14073-3. EPUB AHEAD OF PRINT. PMID: 37639032. THE LITERATURE SOURCE REPORTED A RETROSPECTIVE STUDY OF FIFTY-EIGHT CHEMOTHERAPY-NAIVE PATIENTS WERE IDENTIFIED OUT OF 546 PATIENTS WITH UNRESECTABLE CRLM (COLORECTAL LIVER METASTASES) MANAGED WITH HAI BETWEEN 2003 AND 2019. THE FOLLOWING ADVERSE EVENTS WERE REPORTED IN THIS STUDY: SURGICAL SITE INFECTION, ANASTOMOTIC LEAK (INTESTINAL), ILEUS (PARALYTIC), PUMP-RELATED INFECTION, FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193672 CODMAN 3000 IMPLANTABLE DRUG DELIVERY PUMP LKK CODMAN & SHURTLEFF AP03000H 10886704043591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention