EDWARDS LIFESCIENCES, PR SWAN-GANZ VIP/OXIMETRY THERMOD; CATHETER, OXIMETER, FIBER OPTIC
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Model Number 782F75M |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results.A device history record review was unable to be completed as the lot number is unknown.
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Event Description
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It was reported that there was a failure with this swan-ganz catheter (782f75m, lot number unknown).Per the sales representative, during a cabg procedure, after the patient came off the pump, the swan did not show a pa waveform.The anesthesiologist repositioned the swan back until a waveform appeared.When the surgery was completed, the anesthesiologist noticed that there was blood on the floor, but never found the reason.The patient was transferred to the icu and connected to the hemosphere.The temperature was never accurate reading 91 degrees.The swan would not wedge, even with advancement.When the swan was discontinued, the nurse noted that there was blood in the thermistor on the 70cc2 cable.There was no blood on the outside of the cable.There was a clot in the thermistor as well.There was no troubleshooting done.The non-edwards products involved were the introducer and arrow kit.There was no harm or injury to the patient.
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Manufacturer Narrative
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The product lab received one 782f75m catheter with monoject limited volume syringe, 70cc2 cable, and non-edwards contamination shield.The reported issue of blood in the thermistor was confirmed.As received, blood was observed in thermistor connectors of the catheter and the 70cc2 cable.A 0.08 cut was found on the catheter body at approximately 30.5cm proximal from the tip.The cut entered the thermistor lumen.All through lumen were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.There was no other visible damage was observed from the catheter.All through lumens passed pressure test with lab dpt.The report of inaccurate temperature issue was unable to be evaluated due to the presence of the blood in the thermistor connector.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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