MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BURETROL SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number A2C9801

Device Problem Filling Problem (1233)

Patient Problem Respiratory Distress (2045)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A pediatric patient experienced respiratory distress after the burette of a clearlink buretrol set overfilled. It was reported the burette overfilled ¿1 hour later¿ after initiation of treatment with normal saline and "flucloacillin". The cause of the burette overfill was reported as due to a failed roller clamp (between the iv bag and the burette chamber). A full line change was required. It was reported the patient was fluid restricted. The amount of the fluid overfill was not reported. Seven hours after the overfill, the patient experienced respiratory distress and was transferred to the intensive care unit. Treatment for the event was not reported. At the time of this report, the patient outcome was not reported. No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BURETROL SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8057042
• MDR Text Key: 126723780
• Report Number: 1416980-2018-07140
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412040431
• UDI-Public: (01)00085412040431
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2023
• Device Catalogue Number: A2C9801
• Device Lot Number: DR18C12025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2018
• 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

Patient Treatment Data

Date Received: 11/09/2018 Patient Sequence Number: 1

Treatment

"FLUCLOACILLIN"; NORMAL SALINE