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

Catalog Number HS-008

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

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

On 02/22/2024, infutronix received a report that an iv administration set had a "tubing issue- physcal damage dued to the pump had been dropped hard and cut the tubing and caused it to leak".The infusion cannot resume without causing delay in treatment.

Manufacturer Narrative

The affected administration set was not returned for evaluation.

• Brand Name: ADMINSTRATION SET FOR 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: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 18789356
• MDR Text Key: 336564452
• Report Number: 3011581906-2024-00203
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HS-008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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