MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET; STOPCOCK, I.V. SET

Catalog Number 2C8931

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the clearlink system continu-flo solution set was unable to prime.The reporter stated that the tubing would not flow once spiked.This event occurred during set up.It was stated that the connection between the manifold and the tubing section distal to the patient was the area where no flow was occurring.The customer stated they disconnected and reconnected at the manifold to resolve the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial; itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial; itabo, zona; haina ; DR
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5802499
• MDR Text Key: 49813157
• Report Number: 1416980-2016-11966
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2016

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: 2C8931
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/19/2016
• 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