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

Catalog Number HS-008-B

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Infutronix is waiting for the device to be returned for evaluation.

Event Description

On (b)(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-008-b lot 2008004 was leaking during an infusion, there was so much of a leak that the area of the leak is uncertain." device operator was a registered nurse.Medication infused was 5fu.A patient was involved but not harmed.On (b)(6) 2021, infutronix received additional information from the end user: the set was disconnected from the cassette.The contract manufacturer of the affected device (b)(4).

Event Description

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

Manufacturer Narrative

A service provider of infutronix provided the evaluation report for the affected administration set on 11/01/2021.During the testing, the affected device had no leaking issue.Therefore, the reported issue was not confirmed.

• 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: 12659133
• MDR Text Key: 283175144
• Report Number: 3011581906-2021-00076
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2023
• Device Catalogue Number: HS-008-B
• Device Lot Number: 2008004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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