MAUDE Adverse Event Report: SORIN GROUP ITALIA XTRA AUTOTRANSFUSION SYSTEM; APPARATUS, AUTOTRANSFUSION

Catalog Number	04264
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2016
Additional Manufacturer Narrative
Patient information was not provided.Sorin group (b)(4) manufactures the xtra bowls.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a user medwatch report (mw5062325) on june 13, 2016 stating that the xtra bowl for the xtra autotransfusion system did not empty properly during a procedure.The bowl would partially empty and then stop.The bowl was changed to another from the same lot and the same issue occurred.A third differently sized bowl from a different lot was set up and worked properly.The customer reported that 2000ml of salvaged blood was discarded due to the issue.There was no report of patient injury.The user report stated that an adverse event occurred, however follow-up communication with the customer confirmed that there was no patient injury associated with this event.The impact was the 2000ml of salvaged blood loss that would normally have been lost to the patient without the use of the xtra device.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
Event or Problem Description
Sorin group (b)(4) received a user medwatch report (mw5062325) on june 13, 2016 stating that the xtra bowl for the xtra autotransfusion system did not empty properly during a procedure.The bowl would partially empty and then stop.The bowl was changed to another from the same lot and the same issue occurred.A third differently sized bowl from a different lot was set up and worked properly.The customer reported that 2000ml of salvaged blood was discarded due to the issue.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the xtra bowls.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The complained devices were not returned to sorin group (b)(4) for investigation.According to traceability of the complained devices, sorin group (b)(4) has not received any other reports for similar issues for this lot.As the device was not returned for evaluation, a root cause could not be determined and corrective actions were not identified.No device issue could be confirmed and the occurrence for this type of issue is low.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Device not returned to manufacturer.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo),
• MDR Report Key: 5774159
• Report Number: 9680841-2016-00404
• Device Sequence Number: 686502
• Product Code: CAC
• UDI-Device Identifier: 08033178110808
• UDI-Public: (01)08033178110808(17)190126(10)1601260200
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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: 01/26/2019
• Device Catalogue Number: 04264
• Device Lot Number: 1601260200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1