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

Model Number	AP03000H
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is currently en route but not yet arrived for evaluation at intera.Blank information in the mdr form represents unknown information.When the investigation and evaluation are complete, a supplemental report will be filed.
Event or Problem Description
It was discussed with various officials at a healthcare provider that an adverse event may have occurred with the use of a codman 3000 high flow infusion pump.Implant date was (b)(6) 2018.The surgeon who explanted the device stated to intera that the device was explanted due to 'concern for infection.' additional conversations with the provider stated that the clinical notes were 'unclear,' but there also appeared to be a possible extravasation event.Therefore, the healthcare provider requested a device evaluation to determine if a malfunction had occured or not.The extravasation event was reported to be 04/18/2023.Explant date was reported to be 04/28/2023.It was reported that the mitomycin and fudr (floxuridine) were infused at the time of the event.
Additional Manufacturer Narrative
The dhr for this serial number (b)(6) was reviewed.No deviations or nonconformances pertaining to this serial number were noted in the lot history.The device met all specifications prior to final release.The device was returned to intera evaluated under a testing protocol.The device passed all functional testing that was conducted in this protocol, which was limited to visual inspection, bolus flush, bolus flow test, inadvertent bolus test, and catheter leak test.No malfunction was observed or otherwise noted.The alleged device malfunction could not be confirmed based on this investigation.
Event or Problem Description
It was discussed with various officials at a healthcare provider that an adverse event may have occurred with the use of a codman 3000 high flow infusion pump.Implant date was (b)(6) 2018.The surgeon who explanted the device stated to intera that the device was explanted due to 'concern for infection.' additional conversations with the provider stated that the clinical notes were 'unclear,' but there also appeared to be a possible extravasation event.Therefore, the healthcare provider requested a device evaluation to determine if a malfunction had occured or not.The extravasation event was reported to be 04/18/2023.Explant date was reported to be (b)(6) 2023.It was reported that the mitomycin and fudr (floxuridine) were infused at the time of the event.

• 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: 17577746
• Report Number: 3015537318-2023-00036
• Device Sequence Number: 9006943
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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 Expiration Date: 04/30/2020
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: HJ5686
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2018
• 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 Age: 66 YR
• Patient Sex: Male