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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS SUCTION 12118 LV VENT 18FR PVC 20PK 17L; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
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PERFUSION SYSTEMS SUCTION 12118 LV VENT 18FR PVC 20PK 17L; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 12118
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Atrial Perforation (2511)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
The product has not been received by medtronic and the investigation is in progress.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, additional information received, or if the completed investigation yields new information, a follow up report will be submitted.
 
Event Description
Medtronic received information that during cannulation, the cannula was placed through the atrial septum and perforated the posterior wall of the left atrium of the heart.The surgeon sutured the wall of the atrium.There were no further adverse patient effects.
 
Manufacturer Narrative
The device is not available for analysis because it was discarded by the customer.Without the return of the product, no definitive conclusion can be made regarding the clinical observation in this event.The device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified in the device history record that would have contributed to this event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during cannulation, the cannula was placed through the atrial septum and perforated the posterior wall of the left atrium of the heart.The surgeon sutured the wall of the atrium.There were no further adverse patient effects.
 
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Brand Name
SUCTION 12118 LV VENT 18FR PVC 20PK 17L
Type of Device
SUCKER, CARDIOTOMY RETURN, 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 Key6696295
MDR Text Key79353871
Report Number2184009-2017-00024
Device Sequence Number1
Product Code DTS
UDI-Device Identifier20643169086702
UDI-Public20643169086702
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K834352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Model Number12118
Device Catalogue Number12118
Device Lot Number2016081208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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