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

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

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

A distributor of infutronix received a complaint from a patient, who reported the pump was dropped and it started leaking.Pump was powered down and the cassette was removed to evaluate.On the cassette, it was observed that the tubing at the distal end of the cassette had come loose and separated.This is the area of the leak.Patient was instructed to call her doctor to see if they could swap out tubing or obtain alternative pain management.Device operator was a patient.Medication being infused was unknown.No patient injury reported.The contract manufacturer of the affected device is podo xingda (tianjin) medical co.Ltd.

Manufacturer Narrative

Infutronix is waiting for the affected device to be returned.

• 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 ; 5086502007
• MDR Report Key: 15853342
• MDR Text Key: 305896546
• Report Number: 3011581906-2022-00224
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1