MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC MODEL 3000 - 30ML VOLUME, HIG; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Catalog Number	AP03000H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This initial mdr will be the only report submitted for mfr report #1226348-2018-00660.The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a codman 3000 pump (ap03000h/15501) that had been implanted on (b)(6) 2017, was explanted from a patient due to infection.The patient presented with redness, pain, swelling, and warmth around the pump on (b)(6) 2018 and it was noted that the patient had an infected pump pocket.The infection was located on the patient¿s skin and soft tissues.In addition to explanting the pump, the patient¿s infection was treated with iv abx and po abx.The infection resolved on (b)(6) 2018.The patient was not implanted with a new pump and the patient¿s status is currently improving as the cancer is in remission and hepatic insufficiency.Glycerol was in the pump at the time of explant.Reportedly, the patient has a medical history of cholangio ca, obesity, hepatic insufficiency, depression, anxiety, and cdif infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).Conclusion: codman 3000 pump, serial number (b)(4), was received for evaluation; however, there were no alleged device malfunctions.Therefore, a device investigation is not required.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MODEL 3000 - 30ML VOLUME, HIG
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7718085
• Report Number: 1226348-2018-00660
• Device Sequence Number: 1120841
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: No Information
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 90