MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8891

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Type  Injury  

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 patient experienced chest pain, which required further monitoring and a cta (computed tomography angiography) to evaluate for potential air embolism, while undergoing a surgical procedure in which baxter iv (intravenous) extension set tubing was used.The iv extension set tubing had been used for procedural sedation of the patient during the surgical procedure and was attached to iv set tubing and a solution bag.An unspecified rapid infusion pressure bag was used to increase the rate of infusion and to complete the infusion prior to patient discharge when a sound like water running was heard.The sound was coming from the left antecubital (lac).The iv bag and tubing, all the way to the 20g iv, were empty of fluid and appeared to contain air.The iv was immediately heparin locked.The patient complained of sudden chest pain (six on a scale of ten).The patient was monitored and underwent a cta which showed no sign of air embolism.It was reported that there were no leaks and no visual defects found with the tubing set or the solution bag.The set had primed perfectly and flowed perfectly and there was a normal amount of air at the top of the solution bag prior to beginning the procedure.It was unknown what caused the issue.No further information was provided regarding the patient's outcome from the event.No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The device primed and flowed normally.Functional testing did not verify the reported issue.Sample analysis found no device malfunction or defect that could have contributed to or caused the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5399089
• MDR Text Key: 37129351
• Report Number: 1416980-2016-02190
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2C8891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• 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): Required Intervention