SORIN GROUP ITALIA SRL SORIN BIOMEDICA SMARXT BCD VANGUARD; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
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Catalog Number 050229 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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See initial report.
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