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

Model Number	ARROW 3000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/04/2004
Type of Reportable Event	Death
Additional Manufacturer Narrative
Implant date was determined to be (b)(6) 2003 based on the device tracking database.Based on the age of the complaint, a full investigation may not be able to be completed.If further information is obtained, it will be filed in a supplemental report.It is unknown if this complaint was previously reported to arrow or codman.Infection is a known complication as listed on the labeling of the arrow/codman 3000 device.At this time, it is unknown the exact treatment course for the patient; however, the high flow model (which was used by this patient) is indicated and typically prescribed for hepatic artery infusion for treatment of metastatic cancer.It is unknown the exact relationship between the staph infection and pump.The time between the implant and date of death suggests that the infection was likely not immediately post-operative, although the date of the occurrence of the infection is currently unknown.The manufacture and sterilization of the model 3000 is no longer located where this particular device was produced.There is currently no trend to suggest a field sterility nonconformance with the currently implanted model 3000 devices.
Event or Problem Description
Device tracking card was returned to intera oncology; family member wrote "deceased 2004 from staph infection from pump.".

• Brand Name: ARROW 3000
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11871328
• Report Number: 3015537318-2021-00016
• Device Sequence Number: 11567051
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: ARROW 3000
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR