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

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Return of the device was requested, but the reporter confirmed that the device was discarded.

Event Description

A distributor of infutronix received a complaint from a patient, who reported patient was "getting up from the couch and somehow the tubing got pulled off where it connects the the distal side of the cassette." the pump was powered down, the line was clamped.Upon calling tyhe hospital, the doctor instructed the patient to remove the catheter, which they did.Patient went to er, a new catheter and pump was placed.Patient was "off the pump and receiving no medication from 5pm to nearly 2am in the morning", so several doses were missed.Device operator was a patient.Medication being infused is unknown.No patient injury reported.The contract manufacturer of the affected device is podo xingda (tianjin) medical co.Ltd.

• 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: 15839186
• MDR Text Key: 305895563
• Report Number: 3011581906-2022-00223
• 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: 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

• Date FDA Received: 11/21/2022
• 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
• Date Manufacturer Received: 11/03/2022
• 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