SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problems
Partial Blockage (1065); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Pma 510(k): the heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative inspected the device and confirmed that the oxygenator heat exchanger was blocked due to the particles and that blue-green precipitate was inside the tubes and on the cooling coils of the evaporator.Additionally, the service representative noted degradation of the protecting nickel layer of the cooling coils in the patient tank.The tubes were replaced and a decalcification cycle was performed.The water tanks and bridges were reported to be clean.Pictures of the unit were taken and sent to sorin group deutschland for further evaluation.The investigation is on-going.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that the oxygenator filter became blocked with particles coming from the sorin heater-cooler system 3t during a procedure.Blue-green water was also identified inside the tubes of the device.There was no report of patient injury.
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Manufacturer Narrative
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From follow-up communication, livanova learnt that the customer is maintaining the device as per the guidance provided in the ifu.Livanova has performed comprehensive studies to evaluate the effect of disinfectant on the heater-cooler 3t material.Creation of copper salt was observed during these studies, as well as from devices returned from the field by considering the age of the device claimed in this complaint, and the results of previous investigation, it is reasonable to conclude that the observed colour of the water is resulting from the dilution in the water tank of the above mentioned salts, resulting from a degradation of the device.From the internal studies performed, it is well known that the extent of the corrosion is related to the exposure of the chemicals used for the device disinfection.It is therefore key that the device is maintained according to the instruction for use.
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