MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. D902 LILLIPUT OXYGENATOR PHISIO COATED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number D902 PH.I.S.I.O.

Device Problem Air Leak (1008)

Patient Problem Coagulation Disorder (1779)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of event.Importer (livanova usa) registration number: (b)(4), manufacturer (sorin group (b)(4)) registration number: (b)(4).Sorin group (b)(4) manufactures the d902 lilliput oxygenator phisio coated.The incident occurred in (b)(6).Per exemption number (b)(4), sorin group (b)(4).Is submitting the report for both sorin group (b)(4) (manufacturer) and livanova usa., inc.(importer).The availability of the involved device is unknown at this time.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.Device availability is unknown.

Event Description

Sorin group (b)(6) received a report that an escape of air was observed from the d902 lilliput oxygenator during a procedure and a large amount of foam was noticed.The air reportedly escaped through the upper right side of the reservoir filter.The patient required transfusion therapy of all factors.The patient reportedly suffered from consumption coagulopathy.

Manufacturer Narrative

Sorin group (b)(4) manufactures the d902 lilliput oxygenator phisio coated.The incident occurred in (b)(6).Per exemption number e2016005, (b)(4).Sorin group (b)(4) has been informed that the device involved in the event is no longer available for investigation.Without the ability to perform a physical investigation of the product, a relationship between the reported event and any potential device failure cannot be confirmed, and a root cause could not be determined.No other events have been received against the involved product lot.

• Brand Name: D902 LILLIPUT OXYGENATOR PHISIO COATED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• MDR Report Key: 7008906
• MDR Text Key: 91325336
• Report Number: 9680841-2017-00029
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100397
• UDI-Public: (01)08033178100397(17)200110(10)1701110084
• Combination Product (y/n): N
• PMA/PMN Number: K001021
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: D902 PH.I.S.I.O.
• Device Catalogue Number: 05320
• Device Lot Number: 1701110084
• Distributor Facility Aware Date: 02/08/2018
• Device Age: 8 MO
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 18