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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 Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
Manufacturer Narrative
Product analysis: visual inspection showed no evidence of damage/cracks to the device. The reason for return was not confirmed. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that prior to use of the affinity nt cardiotomy venous reservoirs (cvrs) and oxygenators, it was reported that cracks were seen in the cvrs and oxygenators. The devices were replaced. There was no patient involvement, so no adverse effect occurred. The customer stated that they did not have any problem in the way of storage.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key15094004
MDR Text Key302791542
Report Number2184009-2022-00184
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier20763000232089
UDI-Public20763000232089
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K191029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2022
Device Model Number95215
Device Catalogue Number95215
Device Lot Number13374892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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