MAUDE Adverse Event Report: BAXTER HEALTHCARE CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES; CLEARLINK CONTINU-FLO SOLUTION SET

Catalog Number 2C8537

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient experienced the air embolism on an unreported date in (b)(6) 2015.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an air embolism during a procedure in which a clearlink solution set was used.The cause of the event was unknown.The set was being used to infuse unknown iv fluids prior to a ct scan (computerized tomography scan).No contrast was given during the ct scan.The indication for the ct scan was not reported.There was no noted defect or issue with the set prior to use.It was not reported if the patient was hospitalized for the event.It was reported that the patient did not require any medical intervention and there was no change in the patient铠outcome due to the event (no further detail was provided).No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: the sample was not returned for evaluation and the lot number is unknown, therefore, a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES
• Type of Device: CLEARLINK CONTINU-FLO SOLUTION SET
• 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: 5640883
• MDR Text Key: 44725903
• Report Number: 1416980-2016-08645
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• 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
• Patient Outcome(s): Other