MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE DUO-VENT CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number FNC3121

Device Problem Reflux within Device (1522)

Patient Problem Overdose (1988)

Event Date 09/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink valve backflowed; subsequently, the patient received an overdose of medication.It was reported a labor patient was receiving syntocinon via a colleague pump and compounded sodium lactate (csl) via gravity, both with baxter clear link sets connected to a non-baxter triple lumen extension set.The non-baxter set became occluded due to the patient铠movement of the wrist.The syntocinon infusion travelled the path of least resistance and backflowed into the csl administration set.Unknown at the time the patient was given a bolus of what was thought to be csl and was inadvertently given a bolus of syntocinon.The patient required an emergency caesarean section as a medical intervention.The patient铠recovery status and outcome of the event were not reported.No additional information is available.

Manufacturer Narrative

As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DUO-VENT CLEARLINK LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; ni; singapore ; SN
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6048573
• MDR Text Key: 58129161
• Report Number: 1416980-2016-16544
• Device Sequence Number: 1
• Product Code: FPA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FNC3121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2016
• 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: N
• Patient Sequence Number: 1
• Treatment: COLLEAGUE PUMP; COMPOUNDED SODIUM LACTATE (CSL); NON-BAXTER TRIPLE LUMEN EXTENSION SET; SYNTOCINON
• Patient Outcome(s): Required Intervention