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

Model Number IT1078-CHEMO (IT1078-CHEMO)

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

On 08/23/2023, infutronix received a report that the infusion bag had the tubing broke at the cassette site, causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned for further evaluation.

Manufacturer Narrative

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

• 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 07160
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 18349452
• MDR Text Key: 331070678
• Report Number: 3011581906-2023-00537
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• 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: IT1078-CHEMO (IT1078-CHEMO)
• Device Catalogue Number: IT1078-CHEMO (IT1078-CHEMO)
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 56 KG