Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the helium gas tube was filling up with blood.As a result, the iab catheter was removed from the patient, and another catheter was inserted.The pump was also swapped out as a precaution.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the helium gas tube was filling up with blood.As a result, the iab catheter was removed from the patient, and another catheter was inserted.The pump was also swapped out as a precaution.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).The product was not returned for investigation.The reported complaint that the "helium gas tube was filling up with blood" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the helium gas tube was filling up with blood.As a result, the iab catheter was removed from the patient, and another catheter was inserted.The pump was also swapped out as a precaution.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint that the "helium gas tube was filling up with blood" is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter which allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the helium gas tube was filling up with blood.As a result, the iab catheter was removed from the patient, and another catheter was inserted.The pump was also swapped out as a precaution.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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