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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 20012
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/04/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis visual inspection shows the male luer stem of needle introducer appears to have been inadvertently bonded to the female luer during assembly and when it was removed the luer stem cracked/broke.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that during use of a dlp aortic root cannula with vent line during cardioplegia, the needle in the cannula was more difficult to remove.The device was replaced.No adverse patient effects were reported.
 
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Brand Name
AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA
Common Device Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
MDR Report Key7831998
Report Number2184009-2018-00027
Device Sequence Number11254404
Product Code DWF
UDI-Device Identifier20613994495505
UDI-Public20613994495505
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K810548
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician Assistant
Type of Report Initial
Report Date (Section B) 08/30/2018
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
Operator of Device Health Professional
Device Expiration Date09/30/2020
Device Model Number20012
Device Catalogue Number20012
Device Lot Number2017090539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/06/2018
Initial Report FDA Received Date08/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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