MAUDE Adverse Event Report: INFUTRONIX, LLC ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP; IV ADMINISTRATION SET

Model Number HS-008-B

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021, the complaint handling technician of infutronix confirmed with the user facility that the affected device was discarded and therefore no root cause could be established.The reported issue was not confirmed.

Event Description

On (b)(6) 2021, a complaint handling technician of infutronix reported an issue on behalf of an end user: "an administration set model hs-008-b lot 2007003 set came apart at the back check valve.This has happened on three sperate occasions, dating back to last week." device operator was a patient.Medication infused was 5fu.A patient was involved but not harmed.On (b)(6) 2021, the complaint handling technician of infutronix reported additional information from the end user: "these sets got stuck on a door handle and they broke apart, and they were discarded and will not be returned." the contract manufacturer of the affected device is (b)(6) medical co.Ltd.

Manufacturer Narrative

On 07/28/2022, infutronix confirmed with the end user that the affected device will not be returned for evaluation and therefore a root cause could not be established.

Event Description

This is a follow-up for the initially filed mdr.

• Brand Name: ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): INFUTRONIX LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760
• MDR Report Key: 12097449
• MDR Text Key: 259991778
• Report Number: 3011581906-2021-00040
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2023
• Device Model Number: HS-008-B
• Device Lot Number: 2007003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2020
• 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