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

Model Number	CODMAN 3000
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hydromorphone was stated as the infusate; the codman 3000 is not indicated for hydromorphone.Flow rates are specified for the indicated labeling as per the codman 3000 ifu and label.The intraspinal flow rate is specified per the manufacturer's label is within +/- 15%.For a pump flow rate of 0.5 ml/day, this would be a maximum flow rate of 0.575 ml/day with the indicated infusates.The reported refill interval per the refill nurse suggests a flow rate of 0.625 ml/day.Therefore, this incident is being classified as an alleged malfunction, although no reported harm has come to the patient at this time nor is a malfunction of the device confirmed.Additionally, it is undetermined if using the infusate hydromorphone affects the flow rate of the pump over time, as this drug is not indicated.The lot number, manufacturer, and expiration date of the drug was not provided.Per the codman 3000 ifu, flow rate changes can occur as a function of body temperature, exposure to warm temperatures (e.G.Heating pad), exposure to higher altitudes or extended plane flights.The information provided from the refill rn stated that the patient may have had occasional air travel but does not indicate any other factors as known.As the pump has not been explanted, physical analysis cannot be conducted to conclusively determine the cause of the alleged malfunction.If further information is received regarding this incident, a supplemental report will be filed.
Event or Problem Description
Refill rn called the clinical call line to describe a codman 3000 druge delivery pump that appears to have sped up in recent years.They reported that this change in flow rate has happened "very slowly" over time.First, the refill cycle would be every 55 days, then became 50 days, then most recently became 48 days (without receiving any volume back from the refill).The pump was described as a codman 30 ml pump for intrathecal use.The refill rn stated the drug is 1 mg/ml hydromorphone.The rn stated that the she doesn't believe the patient is heating the pump.The patient has shown no signs of overdose or withdrawal.The refill rn stated the patient expressed desire to be weaned off of the medication because he does not want to use the pump anymore, and is not interested in pump replacement.The pump is not explanted and not available for further evaluation at this time.

• Brand Name: CODMAN 3000
• Common Device Name: DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11758239
• Report Number: 3015537318-2021-00004
• Device Sequence Number: 3438540
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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 Model Number: CODMAN 3000
• Device Catalogue Number: AP03000L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 54