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

Catalog Number AMC9668

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that a continu-flo solution set leaked medication when purging the equipment.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection with the naked eye was performed which observed that the check valve was assembled in the wrong orientation.A functional flow test was performed starting from where the spike was inserted into a saline bag; no leak was observed, however, the flow of liquid was only until the check valve and no flow was present after this location.The reported condition of leak was not verified; however, the device did not meet specification due to the incorrect orientation of the check valve.The cause of the condition was determined to be a manual assembly issue during the manufacturing process.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: 18418919
• MDR Text Key: 331605986
• Report Number: 1416980-2023-06826
• 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,Followup
• Report Date: 02/05/2024

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: Health Professional
• Device Catalogue Number: AMC9668
• Device Lot Number: 23F02V857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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