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

Model Number AP03000M

Device Problem Infusion or Flow Problem (2964)

Patient Problem Confusion/ Disorientation (2553)

Event Date 12/24/2021

Event Type  Injury  

Event Description

A call to the clinical call line by a healthcare provider was received stating that a patient arrived at the hospital and admitted to the icu overnight on (b)(6)2021.As described by caller, the patient was "confused, combative, disorientated" and was given narcan when he arrived.According to the caller, the patient has a codman pump and the last refill date was (b)(6)2021 and the patient was administer 30 ml of morphine in pump dosed as 8 mg per day.The caller stated the patient may have fallen at home and has bruise at pump site.The patient response to narcan was not confirmed by the icu staff.Intera clinical spoke to the icu staff multiple times on (b)(6)2021 and instructed them to empty the pump.Intera clinical personnel offered to travel to the icu site to assist with accessing the pump, but the offer was declined.The icu attempted to access the pump to empty it using a 22 gauge needle that was not from an intera refill kit.When initially accessed, the icu staff report no infusate was returned.The icu staff later attempted to re-access the pump and aspirated and received 0.5-1 cc of infusate.They reported that the patient was placed on a fentanyl drip to treat suspected withdrawal.Icu staff did not attempt to refill the pump and placed the patient on oral medication for pain control.Intera clinical spoke to the icu staff on the (b)(6)2021 and was informed the patient was doing better and no additional clinical assistance was required from intera.The date of patient discharge was not reported.The patient later had a follow up appointment with his regular refill physician on (b)(6)2022.The refill physician reported to intera clinical that the pump returned at least 20 ml of infusate, meaning that the pump still contained the morphine infusate from the refill on (b)(6)2021.He suggested that the icu staff did not correctly access the pump.The refill physician stated that the pump has not flowed correctly for some time, but he has not performed any diagnostics tests or interventions pertaining to the pump function (such as a dye study to confirm catheter patency).The refill physician stated the pump will not be explanted at this time due to the overall patient health condition, at least partially related to renal failure.

Manufacturer Narrative

Based on the statements in from both the icu staff and regular refill physician, there is a difference in medical opinion as to the nature and cause of the alleged adverse event.The root cause of the event cannot be confirmed and the device is not available for evaluation.Blank information in the mdr form represents information not known at the time of this report.If additional information is received, a supplemental report will be filed.

• Brand Name: CODMAN 3000
• Type of Device: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• Manufacturer (Section G): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• Manufacturer Contact: sarah lapp ; 65 william street; suite 200; wellesley, MA 02481 ; 7814895724
• MDR Report Key: 13338768
• MDR Text Key: 287142023
• Report Number: 3015537318-2022-00002
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704043614
• UDI-Public: 10886704043614
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AP03000M
• Device Catalogue Number: AP03000M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male