ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model 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 10/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: as the device was not returned to the manufacturer, a physical evaluation 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 user facility reported that a combi set blood leak occurred at the beginning of a patient¿s hemodialysis (hd) treatment.Blood was observed dripping externally from the venous side of the device, at the blue plastic connector that screws onto the needle.Almost immediately after the leak was seen, the machine alarmed with a message indicating there was air in the lines.No leaking was observed during the priming phase.The patient¿s treatment was stopped after the alarm went off.Upon closer inspection, it was reported that a visible crack was identified on the blue connector.The patient¿s blood was not returned; estimated blood loss (ebl) was 100 ml.Follow-up with the clinic¿s facility administrator (fa) 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 re-setup with new supplies on the same machine.The combi set was not available to be returned for evaluation as it was reportedly discarded.
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