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

Model Number	AP03000H
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Catheter occlusion is a known potential complication as listed on the device labeling.It typically occurs when there is an interruption of flow from the pump due to lack of infusate (either from miscalculation of the refill volume or from intentionally skipping/stopping refills).The date of the event is unknown.The patient's family member did not provide the drug regimen, refill intervals, bolus pathway interventions, and other therapies/treatments, so it is unknown at the time of this report as to lead up to events prior to the catheter occlusion.The patient weight and exact age are unknown.If further information is provided, it will be filed in a supplemental report.
Event or Problem Description
Patient family member called clinical call line stating that patient's hepatic artery infusion pump, implanted (b)(6) 2017, can no longer be used.The patient's catheter has "embolized" according to the patient's family member.As stated by the family member, the refilling physician said the embolism was caused by the patient's radiation treatments, and that the pump may no longer be utilized for therapy.
Event or Problem Description
Patient family member called clinical call line stating that patient's hepatic artery infusion pump, implanted (b)(6) 2017, can no longer be used.The patient's catheter has "embolized" according to the patient's family member.As stated by the family member, the refilling physician said the embolism was caused by the patient's radiation treatments, and that the pump may no longer be utilized for therapy.
Additional Manufacturer Narrative
A review of the communications between the reporter and the clinical specialist was conducted pertaining to the description of the adverse event.Reporter stated that hepatic artery, not the pump catheter, had embolized due to radiation.The detailed timeline on patient therapy and notes as provided from reporter: date of radiation to the liver, started (b)(6) 2021 for 5 days, spleen embolism was detected (b)(6) 2021, mitomycin was delivered via the bolus pathway (b)(6) 2021.Medication was delivered successfully; however, 'there was significant spasm of the proper hepatic artery that responded to nitroglycerin administration,' interval thrombosis of the common hepatic artery noted (b)(6) 2021.Reporter stated patient's physician stated that pump cannot be used for hepatic artery infusion due to hepatic artery embolism.A review of the device history record was conducted.There was one nonconfrmance pertaining to the sterilization cycle, in which sterilization parameters were not initially met.The product was re-sterilized using approved rework procedures and passed all specifications.Based on the clarified information, no device malfunction or product problem is detected.The cause of the adverse event appears to be related to the affect of radiation on the hepatic artery independent of the pump function.The radiation therapy is independent of hepatic artery infusion treatment.

• Brand Name: CODMAN 3000
• Common Device Name: DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11758308
• Report Number: 3015537318-2021-00005
• Device Sequence Number: 3438541
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: AP03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: C91670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MITOMYCIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR