MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Air Embolism (1697)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced air in the vascular system while undergoing a procedure in which a one link extension set was used.The patient was receiving an unspecified contrast injection with a high pressure injector (non-baxter product) which was connected to a one-link extension set and an iv (intravenous) catheter (non-baxter product).The customer stated that a whistling sound could be heard coming from the extension set and the iv catheter.During the infusion, a loose connection was noted between the extension set and iv catheter and the customer was unable to tighten the connection.The pump rate was set to high pressure injection of contrast (2-5 ml per second).There was no leak observed.Air was noted in the vascular system upon further diagnosis testing.It was not reported if the patient required medical intervention.The cause of the loose connection was not reported.No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; ni
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7685316
• MDR Text Key: 113888986
• Report Number: 1416980-2018-04290
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• 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: INSYTE AUTOGUARD CATHETER, BD; MEDRAD POWER INJECTOR
• Patient Outcome(s): Other
• Patient Age: 70 YR