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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL SORIN BIOMEDICA SMARXT BCD VANGUARD; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA SRL SORIN BIOMEDICA SMARXT BCD VANGUARD; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 050229
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information were not provided.The sorin biomedica smarxt bcd vanguard (item 050229, lot number 1906190020) is a non-sterile device that was assembled into convenience pack catalog number 627164801 lot 1922700035 and sterilized before distribution and use in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).The sorin biomedica smarxt bcd vanguard was assembled into a convenience pack distributed in the usa.The non-sterile cardioplegia heat exchanger is also distributed in the usa (510(k)number: k021830).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the cardioplegia heat exchanger was assembled.Sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The incident occurred in (b)(6), usa.The involved device has been requested for return to sorin group italia for investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received a report that, during a procedure, air was seed in the top part of the bcd vanguard cardioplegia heat-exchanger- the medical team elected to change-out the device.There was no report of patient injury.
 
Manufacturer Narrative
H.10 sorin group italia manufactures the sorin biomedica smarxt bcd vanguard.The incident occurred in (b)(6) usa.The complained bcd vanguard was returned to livanova for investigation.Visual inspection found no problem nor any defect.The bcd vanguard was filled and verified if air was entering in the device.Laboratory test could not reproduce the claimed problem.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on investigation results, no direct relationship between the complained event and any device related malfunction has been established.As no specific failure of the device to meet specifications has been reproduced and confirmed, no corrective action will be taken in place for the time being.As the frequency of this type of event is low, no corrective action will be undertaken.Livanova will keep monitoring the market.
 
Event Description
See initial report.
 
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Brand Name
SORIN BIOMEDICA SMARXT BCD VANGUARD
Type of Device
HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena
MDR Report Key9348160
MDR Text Key197319347
Report Number9680841-2019-00040
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/23/2019
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
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Catalogue Number050229
Device Lot Number1906190020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/23/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received03/18/2020
Patient Sequence Number1
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