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

Model Number HS-008 ADMINISTRAION SET (MANUFACTURED BY XINGDA)

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

Patient reported the pouch their pump was in was soaked.I advised them to turn the pump off, clamp the line, and place the bag inside another one.I advised them to wash their hands after handling the pouch.They were going to call the clinic first thing in the morning.The next day the healthcare facility provided visual evidence of damage to the tubing.Medication being infused was an unknown chemo drug.No patient injury reported.

Manufacturer Narrative

Device has been discarded due to risk of contamination.Therefore return of device is not requested.

• 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: 17979789
• MDR Text Key: 326265540
• Report Number: 3011581906-2023-00189
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HS-008 ADMINISTRAION SET (MANUFACTURED BY XINGDA)
• Device Catalogue Number: HS-008 ADMINISTRAION SET (MANU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2023
• 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: 74 YR