MAUDE Adverse Event Report: SORIN GROUP ITALIA XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/125; APPARATUS, AUTOTRANSFUSION

Model Number	BOWL SET X/125
Medical Device Problem Code	Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/06/2017
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/125.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 returned 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 small (approximately 2-3 mm in size) black particles were noted within the salvaged blood that was processed with the xtra autotransfusion system and sent to the re-infusion bag.Re-infusion was not performed and the whole procedure set was put aside.There was no patient involvement.
Additional Manufacturer Narrative
Sorin group italia manufactures the xtra autotransfusion system, procedure set bx/125.The incident occurred in (b)(6).Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The complained circuit (rbc bag, bowl and tubings) was returned to sorin group italia for investigation.Visual inspection of the returned rbc bag confirmed the presence of extraneous black particles.Chemical analysis of the particles identified the presence of carbon compatible with the graphite of the bowl ring.Inspection of the graphite ring did not identify any surface abnormalities or defects.The state of the ring was consistent with standard use.A potential deviation in the physical/mechanical characteristics of the device or incorrect sealing of the bowl top could be ruled out.Improper set up of the disposable in the machine could also not be excluded.A dhr review of the complained circuit confirmed that the disposable was released conforming to product specifications.A review for similar events confirmed that this is an isolated case.As no specific root cause could be identified, corrective actions were not determined.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/125
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• MDR Report Key: 7008919
• Report Number: 9680841-2017-00030
• Device Sequence Number: 16492314
• Product Code: CAC
• UDI-Device Identifier: 08033178110020
• UDI-Public: (01)08033178110020(17)200731(10)1708020126
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 04/12/2018

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: 07/31/2020
• Device Model Number: BOWL SET X/125
• Device Catalogue Number: 04251
• Device Lot Number: 1708020126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Distributor Facility Aware Date: 10/10/2017
• Device Age: 2 MO
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1