MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number AMC9668

Device Problems Obstruction of Flow (2423); Protective Measures Problem (3015)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a continu-flo solution set had an obstruction; the pump alarmed for occlusion.This was observed after placing the set to start hydration.When a syringe was connected to the device, the device did not allow the infusion to continue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, two (2) retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Push-pull testing on all junctions was performed, and no disconnections were noted.Underwater leak testing and air passage testing were performed, with no issues noted.Traction testing was also performed with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18924628
• MDR Text Key: 337913436
• Report Number: 1416980-2024-01175
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413765578038
• UDI-Public: (01)05413765578038
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMC9668
• Device Lot Number: 23F05V860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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: UNSPECIFIED INFUSION PUMP.