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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION; FLOWMETER, BLOOD, CARDIOVASCULAR Back to Search Results
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.
 
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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 Key12568886
MDR Text Key274510453
Report Number1416980-2021-06052
Device Sequence Number1
Product Code DPW
Combination Product (y/n)Y
Reporter Country CodeSW
PMA/PMN Number
NI
Number of Events Reported1
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 NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received10/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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