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

Catalog Number	AP03000L
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Overdose (1988)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This initial/final mdr will be the only report submitted for mfr report #1226348-2018-00744.Manufacture date: 03/2010 expiration date: 03/2012 additional initial reporter information was requested; however, is unknown.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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.
Event or Problem Description
It was reported by a healthcare professional that a patient's codman 3000 pump (ap03000l/(b)(4)), used for pain control, was malfunctioning and the patient was showing signs of overdose following a refill of the pump with morphine and clonidine on (b)(6) 2018.The patient was taken to (b)(6) hospital in (b)(6) and placed in the icu on that date.There were no alarms noted on the pump.No physicians were willing to empty the codman 3000 pump at this facility.The final decision at the time was to wait until the patient's pain physician could be contacted.The patient was treated for overdose with narcan.The patient did not have a fever and no heat had been applied to the pump implant site.The pump was emptied on an unknown date and refilled with preservative free normal saline.The pump remains implanted and is flowing at the expected rate.The patient was still hospitalized as of (b)(6) 2018.

• Brand Name: MODEL 3000 - 30ML VOLUME, LOW
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7930793
• Report Number: 1226348-2018-00744
• Device Sequence Number: 19262939
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AP03000L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2018
• Initial Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention