MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N3348

Device Problems Filling Problem (1233); Defective Component (2292)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a non-dehp micro-volume extension set overinfused while being used with a non-baxter medical pump.A syringe pump was used to infuse fentanyl for premedicated intubation.The syringe was prepared as per protocol and an extra 0.2mls was added to the syringe.The pump was programmed correctly and had an independent double check.The pump infused the whole syringe, including the extra 0.2mls, and rang off with time left in the administration time.The tubing set that had a larger bore than normal.This was observed during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705 ; * 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15485349
• MDR Text Key: 301566245
• Report Number: 1416980-2022-05053
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K811078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

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: Other
• Device Catalogue Number: 2N3348
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FENTANYL; SMITH MEDICAL 3500 PUMP