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 Known Impact Or Consequence To Patient (2692)

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 secondary medication set would not flow during infusion.The reporter stated that the set had been primed and the infusion started; however, when the clinician returned at the end of the expected therapy time, the secondary set was not flowing.The device was being used with a non-baxter primary set and a non-baxter infusion pump.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

One (1) actual device and two (2) unused companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All three returned samples primed and flow tested.All of the samples performed 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: 6771797
• MDR Text Key: 82022307
• Report Number: 1416980-2017-06429
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Catalogue Number: 2C7462
• Device Lot Number: SR17D12039
• 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: 08/29/2017
• 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