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

Model Number	AP03000H
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record, work order#: (b)(4), was reviewed.There were no nonconformance's pertaining to this serial number.The device met all specifications prior to release from manufacturing.The use of glycerin is indicated for use in the intera 3000 pump as specified in the ifu.As previously mentioned, the clinic completed flow study and no obstruction as found in the pump.
Event or Problem Description
Intera oncology, received a report from clinic of high residuals of glycerin in the pump.The clinic originally dispensed 30ml of glycerin to the pump.On (b)(6) 2024, on the patient's scheduled 9 week glycerol flush, the clinic flushed 30 ml of residual.The clinic completed flow study on (b)(6) 2024 and no obstruction was found.The glycerin lot number the clinic used was 0004605665 and the expiration date was october 2027.This lot was manufactured by alk laboratories.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTED DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; ste 300a; newton MA 02459
• Manufacturer Contact: jesus matos ; 180 wells avenue; ste 300a; newton, MA 02459
• MDR Report Key: 20486781
• Report Number: 3015537318-2024-00085
• Device Sequence Number: 4095752
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: AP03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: HC8452
• 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: 09/24/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2017
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White