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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BB811
Device Problems Crack (1135); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/02/2022
Event Type  malfunction  
Event Description
Medtronic received information that during use of a fusion oxygenator, the customer reported that the oxygenator had cracks and blood was running when the machine was on. The device was replaced to complete the procedure. There was no patient impact associated with this event. Medtronic received additional information that the amount of blood lost because of the issues was 200 ml and a transfusion was not required because of the device issue. There was blood leaking from the cracks. The customer stated that there was no leak from the base of the oxygenator and that there was no damage to the packaging or other contents within the package. The customer observed that there was air in the system/tubing.
 
Manufacturer Narrative
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.
 
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Brand NameFUSION HOLLOW FIBER OXYGENATOR
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 Key15144773
MDR Text Key302772208
Report Number2184009-2022-00193
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K183490
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 10/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberBB811
Device Catalogue NumberBB811
Device Lot Number223893771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2022
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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