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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION FLOW COUPLER; FLOWMETER, BLOOD, CARDIOVASCULAR Back to Search Results
Catalog Number 515101250010
Device Problem Structural Problem (2506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 2.5mm flow coupler was misaligned.This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h6 and h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
FLOW COUPLER
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 60073
2242702068
MDR Report Key19047113
MDR Text Key339477592
Report Number1416980-2024-01534
Device Sequence Number1
Product Code DPW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/26/2024
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 Other
Device Catalogue Number515101250010
Device Lot NumberSP23L08-1988246
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/04/2024
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received04/26/2024
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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