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 04/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the material and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
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Event Description
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A user facility reported that a blood leak occurred approximately 1 ½ hours after initiation of the patient's hemodialysis (hd) treatment.The blood leak was noted as being a bloodline tubing leak.The machine did not alarm as it is not intended to do so.Blood was visually observed leaking externally from the red connector of the arterial bloodline to the heparin line.The connection did not completely disconnect; it was reported to be ¿loose¿.Other than the loose connector on the arterial bloodline, no damage was observed to the tubing.Additionally, no damage to the bloodline packaging was observed.The patient¿s estimated blood loss (ebl) was noted as being approximately 200 cubic centimeters (cc).No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up on the same machine.The complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
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