Model Number BOWL SET X/125 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2023 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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See initial report.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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