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

Model Number HS-002

Device Problems Break (1069); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, a distributor of infutronix reported the following on behalf of a patient end user : "patient reported the bag being very wet and couldn't tell where the leaking was coming from.After drying the medication and pump, she saw the administration set snapped at the side and broke." device operator was a patient.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(4).

Event Description

This is a follow-up for the initially filed mdr (3011581906-2020-00023).

Manufacturer Narrative

The evaluation report was provided by the service provider on (b)(6)2020 and confirmed the reported issue.The administration set cassette connector was broken in half, indicating the pump was still engaged to the cassette when force was applied at an angle to the side of the pump at the tubing connection site, causing the connector to snap.Broken iv set issue is confirmed.The affected set has been scrapped.

• 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
• MDR Report Key: 10488429
• MDR Text Key: 206382702
• Report Number: 3011581906-2020-00023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00817170020048
• UDI-Public: 00817170020048
• Combination Product (y/n): N
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HS-002
• Device Catalogue Number: HS-002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1