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 Codes	Overdose (1988); Confusion/ Disorientation (2553)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This initial/final mdr will be the only report submitted for mfr report #1226348-2018-00678.Device manufacture and expiration dates are unknown as the serial/lot number are 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 codman 3000 pump (ap03000l/unk serial number) was refilled on (b)(6) 2018 and the physician ordered the patient¿s pump to be emptied of morphine on (b)(6) 2018.On (b)(6) 2018, 30 ml of morphine 3 mg/ml were placed into the pump at approximately 2:00 pm.At 1:00 pm on (b)(6) 2018 the return was 28 ml, when it should have been 29.5 ml.The patient received 6 mg of morphine as opposed to 1.5 mg in 23 hours.The patient was admitted to the hospital for altered mental status.The pump was implanted in the patient in 1998.The non-core needle supplied with the refill kit was used for each refill.There was no evidence of leakage coming from the septum and no difficulty encountered during refill.The pump has not been explanted from the patient as the patient does not want to have surgery at this time.Instead, the pump was filled with saline on (b)(6) 2018 and then put on oral medication.The patient was monitored in the hospital and reported to be stable.The patient¿s original diagnosis is unknown.

• 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: 7768143
• Report Number: 1226348-2018-00678
• Device Sequence Number: 13510054
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 06/14/2018
• Initial Report FDA Received Date: 08/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 57