MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL XTRA BOWL SET X/125; APPARATUS, AUTOTRANSFUSION

Model Number	BOWL SET X/125
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia has received a report that, during a procedure, the xtra centrifuge bowl exploded at the start of blood processing.Part of the patient blood could be recovered and transfused to the patient.Patient blood was sprayed in the operating room and on person of the medical team.There is no report of any patient/user injury.
Additional Manufacturer Narrative
Patient information were not provided.H.10.Sorin group italia manufactures the xtra bowl set x/125.The incident occurred in france.According to the review of previous similar events, ats bowl leak/breakage is associated to a sudden increase of pressure in the ats bowl.The most probable contributing factors of the pressure increase are: unintentional and accidental occlusion the waste line included in the bowl set (user error), unintentional and accidental operating error during the emptying phase or during the replacement of the ats waste bag included in the bowl set (user error), sudden formation of blood clots inside the ats bowl that causes the clogging the ats bowl outlet.The blood clot formation is generally related to the condition of the collected blood (i.E: prone to clot) or to inadequate anticoagulant dosage.Investigation of the specific event is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Verification of manufacturing records confirmed that involved lot of bowl set (2212100018) was released as conform according to specifications.Analysis of complaints database revealed no other similar cases notified for batch concerned.According to livanova erp (sap), the last preventive maintenance on the complained equipment (sn (b)(6)) was done on 17 november 2022.All test were successfully passed.No visual evidence of reported bowl burst and contamination of xtra centrifuge plate/housing was made available.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: XTRA BOWL SET X/125
• 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 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16992329
• Report Number: 9680841-2023-00018
• Device Sequence Number: 3479429
• Product Code: CAC
• UDI-Device Identifier: 08033178110020
• UDI-Public: (01)08033178110020(17)251209(10)2212100018(240)04251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 12/09/2025
• Device Model Number: BOWL SET X/125
• Device Catalogue Number: 04251
• Device Lot Number: 2212100018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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