MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. XTRA AUTOTRANSFUSION SYSTEM, BOWL SET X/175; APPARATUS, AUTOTRANSFUSION

Model Number	BOWL SET X/175
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	12/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The age of the device was calculated as the time elapsed between the device sterilization and the date of the event.Importer ((b)(4)) registration number: (b)(4), manufacturer (sorin group (b)(4)) registration number: (b)(4).Sorin group (b)(4) manufactures the xtra autotransfusion system, bowl set x/175.The incident occurred in (b)(6).Per exemption number e2016005, sorin group (b)(4).Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4).(importer).A review of the device history record for the involved device lot confirmed that the product was released in compliance with manufacturer specifications.The involved device has been declared to be unavailable for investigation.Sorin group (b)(4) has requested additional information to clarify the potential relationship between the involved device and the patient injury.Based of the information that has been provided, it is unknown at this time if there is a relationship between the device failure and the reported patient injury.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available for return.
Event or Problem Description
Sorin group (b)(4) received a report that a leak from the bowl of an xtra autotransfusion set occurred during blood collection from surgical field.The surgical procedure was conducted due to postpartum hemorrhage.The blood collected could not be processed and the patient had to be given a bank blood transfusion.The customer later reported that the surgical procedure ended with a hysterectomy and sepsis for the patient.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM, BOWL SET X/175
• 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: 7250637
• Report Number: 9680841-2018-00004
• Device Sequence Number: 19017207
• Product Code: CAC
• UDI-Device Identifier: 08033178110037
• UDI-Public: (01)08033178110037(17)200917(10)1709190103
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2020
• Device Model Number: BOWL SET X/175
• Device Catalogue Number: 04252
• Device Lot Number: 1709190103
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/10/2018
• Device Age: 3 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other