MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR; HOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR

Model Number	D902
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier was not provided.Patient sex was not provided.Patient weight was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).(b)(4) manufactures the d902 dideco lilliput 2 infant hollow fiber 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.No other similar complaints have been recorded on this device in the past three years.The involved device is not available 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 available to be returned.
Event or Problem Description
Sorin group (b)(4) received a report that a blood to water leakage occurred in a lilliput 2 infant hollow fiber oxygenator during a procedure.A new oxygenator could not be primed due to the unavailability of blood so the patient temperature was recovered using a heater cooler and blanket.This reportedly took 2 hours.There was no report of patient injury.

• Brand Name: LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
• Common Device Name: HOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 6816109
• Report Number: 9680841-2017-00023
• Device Sequence Number: 162507
• Product Code: DTZ
• UDI-Device Identifier: 08033178100304
• UDI-Public: (01)08033178100304(17)190210(10)1602100009
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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: 02/10/2019
• Device Model Number: D902
• Device Catalogue Number: 05324
• Device Lot Number: 1602100009
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2017
• Device Age: 17 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR