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

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  

Event Description

Patient reported having leaking medication at a blue connector up closer to the port.We powered off the unit and clamped the line.He does have a chemo spill kit and will clean up.Medication being infused was unknown.No patient injury reported.

Manufacturer Narrative

Return of the device has been requested.As of the date of this report, device has not been 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: chaoyung lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 18143813
• MDR Text Key: 328201887
• Report Number: 3011581906-2023-00348
• 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: Other
• Type of Report: Initial
• Report Date: 11/15/2023

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: 11/15/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male