MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/225; APPARATUS, AUTOTRANSFUSION

Catalog Number	04264
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
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 the device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the xtra autotransfusion system, procedure set bx/225.The incident occurred in (b)(6).Per exemption number e2016005.The failed connection was a connection made by the user during set-up of the device on the autotransfusion equipment.Sorin group (b)(4) has determined that this issue was caused by user error.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not available for return.
Event or Problem Description
Sorin group (b)(6) received a report that the blue tubing from the xtra procedure set disconnected from the reservoir during a case and blood spilled on floor and doctor.The tubing was reconnected and the procedure was completed without further issue.There was no patient injury, and no injury was reported for the doctor.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/225
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• MDR Report Key: 6459594
• Report Number: 9680841-2017-00011
• Device Sequence Number: 563828
• Product Code: CAC
• UDI-Device Identifier: 08033178110808
• UDI-Public: (01)08033178110808(17)191114(10)1611140164
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: 11/14/2019
• Device Catalogue Number: 04264
• Device Lot Number: 1611140164
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/07/2017
• Device Age: 4 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1