MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000; IMPLANTABLE DRUG DELIVERY PUMP

Model Number	AP03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Blank fields in the mdr form represent unknown information.If further information is received at a later date, a supplemental report will be file.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• Manufacturer (Section G): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• Manufacturer Contact: sarah lapp ; 65 william street; suite 200; wellesley, MA 02481 ; 7814895724
• MDR Report Key: 18117404
• Report Number: 3015537318-2023-00043
• Device Sequence Number: 6988466
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown