MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK DUO-VENT SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C7462

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system secondary medication set was not infusing.During infusion it was noticed that only the primary solution was being infused and there was no flow from the secondary set.Lacosamide was being administered (200mg) and 20ml 0.9% normal saline using a non-baxter infusion pump.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The primed baxter secondary set was received for evaluation.The secondary set and a non-baxter primary set were spiked into in-house solution bags and re-primed.The male luer of the secondary set was then attached to the y-site luer activated device of the non-baxter primary set.The setup was checked for flow.The device was found to prime and flow normally with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT SECONDARY MEDICATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6825100
• MDR Text Key: 83963441
• Report Number: 1416980-2017-06974
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 2C7462
• Device Lot Number: SR17D24029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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