MAUDE Adverse Event Report: SORIN GROUP ITALIA D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D100 PHISIO
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identification and age were not provided.(b)(6) kg.The age of the device was calculated as the time elapsed between the device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the d 100 l001 ph.I.S.I.O.: newborn hollow fiber membrane oxygenator.The incident occurred in (b)(6).Per exemption number e2016005.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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.
Event or Problem Description
Sorin group (b)(4) received a report that after approx.90 min of the cpb the operator found massive leak of blood from gas outlet of oxy module.The affected oxygenator was replaced by a new one within 8 min during crossclamp.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the d 100 l001 ph.I.S.I.O.: newborn hollow fiber membrane oxygenator.The incident occurred in petah tikva, israel.Per exemption number e2016005, sorin group (b)(4) is submitting the report for both sorin group (b)(4) (manufacturer) and livanova usa., inc.(importer).The involved device was returned to sorin group (b)(4) for investigation.The blood leak reported by the customer was confirmed and the root cause was traced to weak oxygenator fibers that became damaged by thermal and mechanical stresses after release.The oxygenator did pass leak testing during product release activities.However, upon use of the device during a procedure, a leak was triggered.A complaint history review identified that the rate of occurrence for this type of issue is very low, and no injuries have been reported in relation to this type of event.

• Brand Name: D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• MDR Report Key: 7056671
• Report Number: 9680841-2017-00031
• Device Sequence Number: 16607295
• Product Code: DTZ
• UDI-Device Identifier: 08033178100359
• UDI-Public: (01)08033178100359(17)200501(10)1705030267
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K061031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: D100 PHISIO
• Device Catalogue Number: 050531
• Device Lot Number: 1705030267
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/25/2017
• Device Age: 5 MO
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 11/23/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1