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

Model Number AP03000H

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

The complaint does not directly allege a device deficiency; however, to complete a full investigation, the sterilization lot record was reviewed.This device was from final package assembly lot 28787, final assembly lot 28679.The str record (str-0883-20035) was reviewed.No nonconformances or deviations were noted in the sterilization record; total calculated bioburden for the 3 pumps tested in the lot was determined to be less than 2.8 cfu/sip in the inner reservoir.Klebsiella is published as a possible hospital-acquired infection.Per the centers for disease control (https://www.Cdc.Gov/hai/organisms/klebsiella/klebsiella.Html), "patients in healthcare settings also may be exposed to klebsiella when they are on ventilators (breathing machines), or have intravenous (vein) catheters or wounds (caused by injury or surgery)." it is possible that the infection may have been hospital-acquired, although the complainant reported that they could not find the source.Therefore, the root cause is ultimately undetermined.Infection is a known adverse event as published in the intera 3000 ifu.If further information is received at a later date, a supplemental mdr will be filed.Blank fields in the mdr report represents unknown information.

Event Description

An intera 3000 pump was explanted and a replacement implanted.Serial number of explant was sn (b)(4).It was reported that the fluid in the pump was infected.As reported by the clinical specialist: "fluid in the pump was infected.Patient had positive blood cultures and they could not find the source.The high dose [heparin saline] in the pump tested positive.Utilizing standard operating procedure, we prepared the [new] pump.Pump was connected to previously implanted catheter.Pump pocket was made on the right side of the body, opposite of previous pump pocket which was on the left." it was later confirmed by the clinical rep that this was not a pump pocket infection, only an infection located in the pump.The bacteria was reported to be klebsiella.No device deficiency was alleged.

Event Description

An intera 3000 pump was explanted and a replacement implanted.Serial number of explant was sn 16721.It was reported that the fluid in the pump was infected.As reported by the clinical specialist: "fluid in the pump was infected.Patient had positive blood cultures and they could not find the source.The high dose [heparin saline] in the pump tested positive.Utilizing standard operating procedure, we prepared the [new] pump.Pump was connected to previously implanted catheter.Pump pocket was made on the right side of the body, opposite of previous pump pocket which was on the left." it was later confirmed by the clinical rep that this was not a pump pocket infection, only an infection located in the pump.The bacteria was reported to be klebsiella.No device deficiency was alleged.

Manufacturer Narrative

Add reported patient information in supplement.

• Brand Name: INTERA 3000
• Type of Device: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• 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: 15764389
• MDR Text Key: 303396146
• Report Number: 3015537318-2022-00025
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 28787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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: 52 YR
• Patient Sex: Male