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

Catalog Number 2R8537

Device Problem Component Misassembled (4004)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that a clearlink system solution set was incorrectly assembled.This issue was further described as, ¿misfed tubing through clamp¿.This issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed on the photograph which observed that the tubing was not inserted into the roller clamp according to specification.Due to the nature of the sample no further testing could be performed.The the reported condition was verified.The cause of the condition was an improper manual assembly during the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18188089
• MDR Text Key: 329898884
• Report Number: 1416980-2023-06115
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2R8537
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2023
• 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: Initial
• Patient Sequence Number: 1