ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number IPN000254 |
Device Problem
Failure to Zero (1683)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2021 |
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 fos would not zero when it was inserted into the back of the pump.It was noted that the fos clicked in, but there were no beeps.As a result, the staff successfully placed another iab catheter and used another iabp.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).The product was not returned for investigation.The reported complaint of iab fos would not zero 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 fos would not zero when it was inserted into the back of the pump.It was noted that the fos clicked in, but there were no beeps.As a result, the staff successfully placed another iab catheter and used another iabp.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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