MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number BO-HQV 39600 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 11/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.
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Event Description
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According to the hospital: "during an aortic valve replacement associated with coronary bypass surgery on a (b)(6) patient, a blood leak was noticed at the cap of the oxygenator on the extracorporeal circuit.This leak started at the beginning of the ecc procedure and has lasted the entire duration of the procedure (about 1 h to 1h30).The approximate flow rate of the leak was 5 drops/minute, without blood projection.No consequence for the patient.But if the leak moved to the oxygenator, there would have been a risk of gas embolism requiring the oxygenator to be changed, which is an ultimate procedure because it carries a vital risk for the patient.The device has been retained for expertise." (b)(4).
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Manufacturer Narrative
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(b)(4).The product was discarded by the hospital and was unavailable for return.Therefore, a full investigation could not be performed.A dhr review was performed based on the available information.The dhr of the affected packaging lot was inspected and 432 units of oxygenator quadrox-i hmo 71000 have been manufactured from 2016-03-18 until 2016-03-30 with no abnormalities or nonconformities in the dhr.The root cause could not be established.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and if a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation or action is warranted at this time and the complaint will be closed.Please note this is the final report.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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