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

Catalog Number HS-008-B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/27/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-008-b lot 2008004 became disconnected from the distal end of the cassette." device operator was a registered nurse.Medication infused was 5fu.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

A service provider of infutronix provided the evaluation report for the affected administration set on 11/01/2021.Visual inspection confirmed that the tubing connector on the distal end of the cassette module was snapped and broken.The tubing was completely separated from the cassette.The reported issue was confirmed.

Event Description

This is a follow-up for the initially filed mdr 3011581906-2021-00075.

• 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: 12659000
• MDR Text Key: 281081411
• Report Number: 3011581906-2021-00075
• 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