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

Model Number UNKNOWN

Device Problem Disconnection (1171)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Upon review the unknown product cannot be located.This complaint will be reopened in the event the product involved or additional information becomes available.

Event Description

On 09/13/2023, infutronix received a report that the iv set was leaking during infusion.Causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned for evaluation.

• Brand Name: 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 01760 ; 5086502007
• MDR Report Key: 18344166
• MDR Text Key: 331154179
• Report Number: 3011581906-2023-00529
• 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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR