MAUDE Adverse Event Report: SORIN GROUP ITALIA D905 EOS OXYGENATOR (PHISIO TREATED); OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050512

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

The complained d905 dideco eos phisio (catalog number 050512, lot 1704140014) is not distributed in the usa, therefore the udi is not applicable.The complained oxygenator is similar to the d905 dideco eos phisio/m oxygenator 050510, which is distributed in the usa, for which the device identifier is (b)(4).Initial reporter contact phone number is: (b)(6).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The product item 050512 is not distributed in the usa, but it is similar to the d905 dideco eos phisio/m oxygenator item 050510, which is distributed in the usa (510(k) number: k043323).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 8f m hollow fiber 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 obtained, 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 d905 eos 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 and a heterologous blood transfer was performed.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 requested for return to sorin group italia for investigation.However, the unit was never made available and an evaluation could not be performed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on similarity to previously investigated cases, a possible root cause is transient undesired cellular activation, which is multi-factorial in nature and not device specific.

• Brand Name: D905 EOS OXYGENATOR (PHISIO TREATED)
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7684671
• MDR Text Key: 114287583
• Report Number: 9680841-2018-00021
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Catalogue Number: 050512
• Device Lot Number: 1704140014
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2018
• Device Age: 14 MO
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1