MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 3000; HEPATIC ARTERY INFUSION PUMP

Model Number AP03000H

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/15/2024

Event Type  Injury  

Event Description

It was reported by a health care provider: during a refill of an intera 3000 hepatic artery infusion pump, the infusion staff initially saw clear fluid return into the collection syringe.After the initial clear fluid, blood began to fill the syringe.The nurse accessed and received more clear fluid then "bright red blood" appeared.They did receive a total of 13mls fluid, which was the correct amount indicating the pump is flowing correctly.They then proceeded to fill with 30mls of the high dose heparinized saline as they knew they were in the correct placement as they were feeling pressure.They injected all 30mls using the 5mls in 1ml out process and saw no blood returning.The patient was sent for a stat ct scan.It was later reported that the ct scan was reported 'fine' and that the surgeon thinks that it was 'aggressive access' or that the pump pocket was accessed.It was also reported that the rn attempted to access and could not locate septum.She tried multiple times and went through 2 refill kits.She was getting what looked like solution, but she wasn't in the correct spot, this may have been pump pocket fluid.The surgeon then attempted to access twice and finally was in the correct position, no residual, [intera clinical] asked him to inject 5ml's of injectable saline and allow it to return, it did.At this point he deemed the pump was dry.The pump was filled with high dose heparinized saline.A haps (pump study) was later performed, which was reported to be normal.The residuals reported after 2 weeks were also reported to be as expected.

Manufacturer Narrative

The device history record was reviewed.There were no nonconformances or deviations pertaining to this lot.The device met all functional and performance specifications prior to release to manufacturing.Based on the information provided from the customer, there may have been use situations including "aggresive access" [as described by the customer], and/or there may have been a pocket fill that may have caused or contributed to the event.Based on the reported haps study and reported normal residuals upon the latest refill, the device is now performing as expected.The device remains implanted and cannot be further evaluated by intera.Blank fields in the mdr form represent unknown information.If further information is received at a later date, a supplemental report will be filed.

Event Description

It was reported by a health care provider: during a refill of an intera 3000 hepatic artery infusion pump, the infusion staff initially saw clear fluid return into the collection syringe.After the initial clear fluid, blood began to fill the syringe.The nurse accessed and received more clear fluid then "bright red blood" appeared.They did receive a total of 13mls fluid, which was the correct amount indicating the pump is flowing correctly.They then proceeded to fill with 30mls of the high dose heparinized saline as they knew they were in the correct placement as they were feeling pressure.They injected all 30mls using the 5mls in 1ml out process and saw no blood returning.The patient was sent for a stat ct scan.It was later reported that the ct scan was reported 'fine' and that the surgeon thinks that it was 'aggressive access' or that the pump pocket was accessed.It was also reported that the rn attempted to access and could not locate septum.She tried multiple times and went through 2 refill kits.She was getting what looked like solution, but she wasn't in the correct spot, this may have been pump pocket fluid.The surgeon then attempted to access twice and finally was in the correct position, no residual, [intera clinical] asked him to inject 5ml's of injectable saline and allow it to return, it did.At this point he deemed the pump was dry.The pump was filled with high dose heparinized saline.A haps (pump study) was later performed, which was reported to be normal.The residuals reported after 2 weeks were also reported to be as expected.

Manufacturer Narrative

Patient information added to supplement report.

• Brand Name: INTERA 3000
• Type of Device: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 65 william street; ste 200; wellesley MA 02481
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 65 william street; ste 200; wellesley MA 02481
• Manufacturer Contact: sarah lapp ; 65 william street; ste 200; wellesley, MA 02481 ; 7814895724
• MDR Report Key: 18708376
• MDR Text Key: 335406941
• Report Number: 3015537318-2024-00011
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (y/n): N
• 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,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 29231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2023
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Race: White