ICU MEDICAL, INC. TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, HEPARIN COATED; CATHETER, OXIMETER, FIBER-OPTIC
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Catalog Number 52510-14 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 11/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to return to the manufacturer for investigation, however, it has not been received.
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Event Description
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The event involved blood loss that occurred during use of a triox¿ svo2/cco pa catheter.It was reported that the triox cco/svo2 catheter was no longer providing a continuous cardiac output (cco) value when the patient came off bypass.Blood was discovered dripping out of the thermistor hub when the thermistor cable was removed.The event occurred during use on patient for 3 hours.The issue was noticed when there wasn't a cco value on the monitor.No adverse event occurred.
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Manufacturer Narrative
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H10: the device was returned to the manufacturer on december 9, 2019.Received one (1) used list# 52510-14, triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, heparin coated; lot # 4135481 for investigation.The reported complaint of unable to obtain continuous cardiac output (cco) value and blood leak in the hub was confirmed.The electrical characteristics of the thermistor was measured and found to be inconsistent.When the thermistor hub was cut open and hydrostatically leak tested, a leak was observed inside the hub.The thermocoil was uncoiled and the lumen was cut open to determine the cause of the leak.A nick was observed between the distal thermal positioning port (dtpp) lumen and the thermistor lumen.The cause for no cco value is due to the fluid ingress inside the thermistor hub.The probable cause for the nicks in the inner lumen could not be determined.A device history review (dhr) lot# 4135481 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
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