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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA D903 AVANT 2 OXYGENATOR PHISIO COATED; OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA D903 AVANT 2 OXYGENATOR PHISIO COATED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number D903 DIDECO AVANT 2 PHISIO
Device Problem Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.Initial reporter contact phone number is: (b)(4).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the d903 avant 2 physio coated oxygenator.The incident occurred in (b)(6).(b)(4).The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
 
Event Description
Sorin group (b)(4) received a report that transmembrane pressure of the d903 avant 2 oxygenator increased during a procedure.During follow-up communication with the customer on (b)(6) 2018, sorin group (b)(4) was informed that nitroprusside was administered to the patient.There was no report of any patient injury.
 
Manufacturer Narrative
Sorin group italia manufactures the d903 avant 2 phisio coated oxygenator.The incident occurred in edmonton, canada.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved device was returned to sorin group italia for investigation.During visual inspection, no visible defects were noted.The device was tested in order to evaluate the pressure drop in standard conditions.No device malfunction was identified during this testing.The device was found to be conforming to manufacturer specifications.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not determined.However, one possible root cause is transient undesired cellular activation.This root cause is multi-factorial in nature and not device specific.
 
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Brand Name
D903 AVANT 2 OXYGENATOR PHISIO COATED
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola, modena 41037
IT  41037
MDR Report Key7684668
MDR Text Key114416492
Report Number9680841-2018-00019
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier08033178100106
UDI-Public(01)08033178100106(17)200506(10)1705080145
Combination Product (y/n)N
PMA/PMN Number
K033323
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 09/27/2018
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
Device Operator Health Professional
Device Expiration Date05/06/2020
Device Model NumberD903 DIDECO AVANT 2 PHISIO
Device Catalogue Number05338
Device Lot Number1705080145
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/14/2018
Device Age13 MO
Initial Date Manufacturer Received 06/14/2018
Initial Date FDA Received07/13/2018
Supplement Dates Manufacturer Received08/29/2018
Supplement Dates FDA Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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