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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 95215
Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2019
Event Type  malfunction  
Manufacturer Narrative
Device return has been requested. Device will be analyzed on receipt at medtronic's analysis lab. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use, the customer reported the nt oxygenator was unable to oxygenate. The clinician noticed poor to no gas transfer upon start of bypass. Bypass was terminated and device was changed out. When the oxygenator was disconnected from the cvr, the clinician noticed the gas cap was cracked and dislodged. There was no adverse effect to the patient.
 
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Brand NameAFFINITY HFO W/TRILLIUM 511T
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9472547
MDR Text Key196213107
Report Number2184009-2019-00082
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/27/2020
Device Model Number95215
Device Catalogue Number95215
Device Lot Number13304409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2019 Patient Sequence Number: 1
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