MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL. XTRA PROCEDURE SET BX/225; APPARATUS, AUTOTRANSFUSION

Model Number	04264
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the livanova complaints database identified no other analogue issue notified for the batch concerned from the market, neither similar events concerning trend has been identified.According to the review of similar events, the leakage instances from the bottom region of the bowl were traced back to an unexpected internal bowl pressure increase phenomenon possibly triggered by multiple factors such as: - accidental waste line occlusion by user - operating error during waste bag emptying/replacement - clot formation inside the bowl clogging the outlet blood flow path, due to peculiar blood conditions (prone to clot) or inadequate anticoagulant dosage.- centering issue of xtra bowl arm or stuck centrifuge bearings (temporary equipment failure) leading to an out-of axis bowl rotation taking into account the limited data currently available, however, the specific root cause of the bowl breakage event could not be determined.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: sorin group italy manufactures the xtra procedure set bx/225.The incident occurred in lubbock, texas.Through follow-up communication, livanova learned that the perfusionist standing beside the xtra was contaminated with the blood that was escaping.The bowl came apart in the centrifuge when spinning and blood shot out all open sides of the machine.Small cracks were generated in the xtra cover.In addition, a picture showing the bottom plate of the broken bowl laying on the centrifuge housing of the machine was received.The print-out was not provided, so there is no possibility to trace the bowl burst to the specific processing cycle nor to analyze the list of warnings/alarms that popped up before the event.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 italy received a report that the upper portion of an xtra bowl coming separated from the bottom portion that sits in the centrifuge well and as a consequence there was a significant amount of fluid loss.Blood leaked out the bowl and centrifuge and the user was contaminated.The issue occurred during procedure.The bowl plate was left in the centrifuge well and the customer had to use a screwdriver to pry the disposable base from the centrifuge.There was no patient injury.

• Brand Name: XTRA PROCEDURE SET BX/225
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA SRL.; strada statale 12 nord 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 80309 ; IT 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 19674951
• Report Number: 9680841-2024-00019
• Device Sequence Number: 7751171
• Product Code: CAC
• UDI-Device Identifier: 08033178110808
• UDI-Public: (01)08033178110808(17)270111(10)2401120149(240)04264
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 Model Number: 04264
• Device Lot Number: 2401120149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown