Model Number 2477-0007 |
Device Problems
Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Per customer, it is their policy not to provide patient demographics.
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Event Description
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It was reported that the blood tubing set was primed and no leak was observed.After loading the set into the pump, blood was seen dripping from the bottom of the pump.Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module.A tiny tear on the pump segment was noted.There was no patient harm.A photo of the product was provided by the customer.The clinician believes that the pump might have caused the tubing to tear.
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Manufacturer Narrative
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Additional information added; d.10, h.7, and h.9.The customer report that the tubing leaked at the pumping segment was confirmed.Inspection of the set's silicone segment component observed there was a tear, directly below the upper fitment component.A leak was observed from the tear during testing.The set was pressure tested with intent of applying air pressure throughout the set the fluid within the set leaked from the tear at 5psi.The root cause of the tear was not identified.
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Event Description
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It was reported that the blood tubing set was primed and no leak was observed.After loading the set into the pump, blood was seen dripping from the bottom of the pump.Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module.A tiny tear on the pump segment was noted.There was no patient harm.A photo of the product was provided by the customer.The clinician believes that the pump might have caused the tubing to tear.
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Manufacturer Narrative
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The customer report that the tubing leaked at the pumping segment was confirmed.Visual inspection showed a tear in the silicone segment directly below the upper fitment component.The tear was measured approximately 0.0127 inches in length.Fluid was observed leaking from the tear.The set was pressure tested and the fluid within the set leaked from the tear at 5psi.The root cause of the tear was not identified.Functional testing with the returned pump could not be performed due to the tear in the silicone tubing segment.The returned concomitant pump module was routed to service for preventative maintenance/testing before being returned to the customer.The bezel was found to be affected by the alaris pump 8100 separated bezel boss recall and was replaced.However, this issue was unrelated to the tubing tear.The pump passed testing and no fault was found.Device history record for model 2477-0007 lot 19106339 shows that the set was manufactured on 24 october 2019 with a total of 17,283 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
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Event Description
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It was reported that the blood tubing set was primed and no leak was observed.After loading the set into the pump, blood was seen dripping from the bottom of the pump.Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module.A tiny tear on the pump segment was noted.There was no patient harm.A photo of the product was provided by the customer.The clinician believes that the pump might have caused the tubing to tear.
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Search Alerts/Recalls
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