MAUDE Adverse Event Report: SORIN GROUP ITALIA D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D101 PHISIO
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information 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).Sorin group (b)(4) manufactures the d101 kids infant 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 blood leaked from the oxygenator chamber of the d101 kids infant hollow fiber membrane oxygenator during a procedure.The oxygenator was changed out and the patient was given a blood transfusion as a result.There was no report of patient injury.
Additional Manufacturer Narrative
(b)(4).Per exemption number e2016005.The involved device was returned to (b)(4) for investigation.The blood leak reported by customer was confirmed and the root cause was traced to damage to the oxygenator fibers.The damage did not cause a detectable leak during product release testing.However, upon use of the device during a procedure, a leak was triggered.The customer was able to resolve the issue during the procedure by changing the oxygenator.

• Brand Name: D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 6851026
• Report Number: 9680841-2017-00026
• Device Sequence Number: 18848300
• Product Code: DTZ
• UDI-Device Identifier: 08033178109291
• UDI-Public: (01)08033178109291(17)190715(10)1607140083
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072091
• 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,Followup
• Report Date (Section B): 12/28/2017

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: 07/15/2019
• Device Model Number: D101 PHISIO
• Device Catalogue Number: 050540
• Device Lot Number: 1607140083
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/11/2017
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1