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

Catalog Number 2C8541

Device Problems Kinked (1339); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system continu-flo solution set experienced no flow.This occurred during patient use/setup.When the tubing is inserted inside of the sigma pump through the flow line, the tubing set becomes crimped, not allowing fluid to flow.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Device manufacture date: 04/06/2016-04/07/2016.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Clear passage and pressure testing were performed and passed successfully with no issues relating to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5830678
• MDR Text Key: 50686203
• Report Number: 1416980-2016-12325
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2021
• Device Catalogue Number: 2C8541
• Device Lot Number: R16D05102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1