MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; FLOWMETER, BLOOD, CARDIOVASCULAR

Catalog Number ASKU

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

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

It was reported that an unspecified flow coupler did not detect compromised patency.This issue was identified during use of the device.It was further reported the customer believed the device was "detecting a near by flow due to poor placement intraoperatively".There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: NI
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12568886
• MDR Text Key: 274510453
• Report Number: 1416980-2021-06052
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1