ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 03-2722-9 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: the sample was not returned to the manufacturer and a physical evaluation of the device could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
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Event Description
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A clinical care coordinator reported that a fresenius combi set disconnected during a patient¿s hemodialysis (hd) treatment, resulting in blood loss.The heparin line on the arterial end of the bloodline reportedly disconnected from the heparin pump.It was reported that this occurred approximately halfway through the patient¿s treatment.A small amount of blood was observed leaking from the bloodline due to the disconnection.The patient¿s estimated blood loss (ebl) was reported to be less than 5 ml.The operator immediately clamped off the lines and returned the patient¿s blood.The machine, a fresenius 2008t, did not alarm.There were no visible defects on the combi set, and nothing out of the ordinary was noticed during the prime.The reporter confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being set up with new supplies on the same machine.The combi set was discarded after the incident and therefore was not available to be sent back for a physical evaluation.
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