MAUDE Adverse Event Report: INFUTRONIX, LLC IV ADMINISTRATION SET FOR INFUSION PUMP

Model Number ADMINISTRATION SET

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

Upon review the unknown device cannot be located because there is no information provided with this device.This complaint and mdr will be reopened in the event the product involved or additional information becomes available.

Event Description

On 11/7/23, infutronix received a report that an iv set had leakage issue during infusion causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned.

• Brand Name: IV ADMINISTRATION SET FOR 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: frederick lee ; 177 pine street; natick, MA ; 5086502007
• MDR Report Key: 18348156
• MDR Text Key: 331070300
• Report Number: 3011581906-2023-00535
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2023

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
• Device Model Number: ADMINISTRATION SET
• Device Catalogue Number: ADMINISTRATION SET
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR