SORIN GROUP ITALIA S.R.L. INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS
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Catalog Number 03705 |
Device Problems
Increase in Pressure (1491); Low Readings (2460)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier was not provided.Patient age was not provided.The involved inspire 8f m oxygenator was a non-sterile component assembled into a sterile convenience pack that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile finished product is not distributed in usa, there is no unique identifier (udi) number.However, the involved device is similar to inspire 8f m oxygenator catalog number 050703, which is distributed in the usa, for which the device identifier is (b)(4).The date provided is the date the device was returned to sorin group (b)(4) before it was sent for gamma ray decontamination.At the present date, the device has not yet been returned to sorin group (b)(4) from decontamination.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The iinspire 8f m oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050703) is registered in the usa (510(k) number: k130433).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).The review of the dhr for the reported perfusion tubing set lot confirmed that the device was released in compliance with manufacturer specifications.The pump sheet was provided and sorin group (b)(4) has developed a mathematical pressure drop prediction model, able to determine expected min-max values of the inspire pressure drop based on specific operating conditions (flow, hematocrit, arterial temperature, etc.) outlined in the pump sheet.The model run confirmed that the device experienced a pressure excursion above the expectations.The involved device was returned to sorin group (b)(4) and was sent for gamma ray decontamination on the (b)(6) 2017.The device has not yet been returned to sorin group (b)(4) for investigation.However, based on the evidence from previously investigated cases, sorin group (b)(4) believes a likely root cause of the increased pressure to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The failure appears to not be device-specific.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
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Event Description
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Sorin group(b)(4) received a report that high membrane pressure was observed in an inspire 8f m hollow fiber oxygenator during cardiac surgery.As a consequence of the high pressure, the venous saturation dropped below 55%.The oxygenator was changed out to continue the case.The extracorporeal circulation had to be stopped for about 3 minutes the oxygenator change.After the change, the pressure values and the gas exchange capacity were as expected.There was no report of patient injury.
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Manufacturer Narrative
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Sorin group italia manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in rotenburg an der fulda, germany.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and sorin group usa., inc.(importer).The involved device was returned to sorin group italia for investigation following sterilization.Visual inspection of the device did not identify any visible defects.To evaluate the pressure drop under standard conditions, simulated use testing was performed.No device malfunction was identified during this testing.The device was found to be conforming to the manufacturer specifications.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue was not reproduced, a root cause was not determined.However, based on the evidence from previously investigated cases, sorin group italia believes a likely root cause of the increased pressure drop to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The failure appears to not be device-specific.
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