Model Number 03-2722-9 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 03/18/2022 |
Event Type
malfunction
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Event Description
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A user facility clinic manager (cm) reported a blood leak that occurred with a combiset approximately 150 minutes into the patient¿s hemodialysis (hd) treatment.The arterial pressure was high and pushed into the heparin line.The plunger dislodged and blood began squirting out of the transfusor.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or adverse event associated with this event.The patient was hypotensive as a result of the blood leak and saline was administered (per standing order).The patient successfully completed treatment on the same machine with new supplies.There was no defect, damage, or loose connections noted on the combiset.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Manufacturer Narrative
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Additional information: d9, h3 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 clinic manager (cm) reported a blood leak that occurred with a combiset approximately 150 minutes into the patient¿s hemodialysis (hd) treatment.The arterial pressure was high and pushed into the heparin line.The plunger dislodged and blood began squirting out of the transfusor.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or adverse event associated with this event.The patient was hypotensive as a result of the blood leak and saline was administered (per standing order).The patient successfully completed treatment on the same machine with new supplies.There was no defect, damage, or loose connections noted on the combiset.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Additional information: d9, h3 plant investigation: the manufacturer received the complaint product sample with original packaging identified with product number 03-2722-9 and lot number 21nr01152.During visual inspection with a microscope a channel leak was found in the assembly of the heparin line to the red ¿t¿ connector.The sample was tested via simulated use and a leak was found 40 minutes after treatment initiation at the assembly of heparin line to red ¿t¿ connector.The alleged failure mode ¿leak at the heparin line¿ was confirmed during sample evaluation.This kind of failure mode could be attributed to an improper assembly by the operator due to not following the work instruction, does not applying solvent correctly in the components during the manufacturing process (lack of solvent application), or due to a lack of solvent during the assembly of the components (dispenser malfunctioning).
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Event Description
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A user facility clinic manager (cm) reported a blood leak that occurred with a combiset approximately 150 minutes into the patient¿s hemodialysis (hd) treatment.The arterial pressure was high and pushed into the heparin line.The plunger dislodged and blood began squirting out of the transfusor.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or adverse event associated with this event.The patient was hypotensive as a result of the blood leak and saline was administered (per standing order).The patient successfully completed treatment on the same machine with new supplies.There was no defect, damage, or loose connections noted on the combiset.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.
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Search Alerts/Recalls
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