MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000; HEPATIC ARTERY INFUSION PUMP

Model Number	AP03000H
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of the adverse event is unknown.Intera has contacted the author of the study in order to obtain more information regarding the reported malfunction.The author discussed that this complaint was reported to codman previously; however, intera was unable to find a complaint file that matched the malfunction referenced in the publication.Intera has informed the author of this and requested the information regarding the malfunction; however the author has been unable to provide.Thus, intera is unable to complete a full investigation as to the root cause of the apparent malfunction.If any further information on this malfunction is obtained, a supplemental report will be filed.Serial number and implant date were obtained from device tracking system based on the implant timeframe stated in the publication.
Event or Problem Description
The publication ''combined systemic and hepatic artery infusion pump chemo-therapy as a liver-directed therapy for colorectal liver metastasis-review of literature and case discussion," cancers (2021) volume 13 was published and made available online.It decribes a case study in which a hepatic artery infusion pump "malfunctioned.".

• Brand Name: CODMAN 3000
• Common Device Name: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11676331
• Report Number: 3015537318-2021-00003
• Device Sequence Number: 3015582
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP03000H
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR