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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE ACCESS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8519
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chest Pain (1776)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 rule out an air embolism, while undergoing a surgical procedure in which a baxter iv (intravenous) access set was used. The iv access infusion set had been used for surgical procedural sedation of the patient during an incision & drainage of a cyst and was attached to an extension set and a solution bag. An unspecified rapid infusion pressure bag was used to speed up 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 both 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 with 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 had 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). A non-baxter sample was returned. Upon further investigation, it was confirmed the access device was a non-baxter product; therefore, the intravenous access set is no longer considered a suspect product in this event. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameACCESS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE
600 mts oeste de entrada
cartago
CS
Manufacturer (Section G)
BAXTER HEALTHCARE
600 mts oeste de entrada
cartago
CS
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5374768
MDR Text Key36197924
Report Number1416980-2016-01294
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2H8519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
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 Unkown

Patient Treatment Data
Date Received: 01/18/2016 Patient Sequence Number: 1
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