ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number IPN000254 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2021 |
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 staff had helium loss alarms.As a result, the staff extended the patient's hip and decreased the volume to 27cc.The clinical support specialist explained that there could be a kink in the catheter and if the problem persists, they could exchange the catheter.No further issues were reported.There was no report of delay in therapy.There was no report of patient complication, 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 helium loss alarm 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.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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 staff had helium loss alarms.As a result, the staff extended the patient's hip and decreased the volume to 27cc.The clinical support specialist explained, that there could be a kink in the catheter.And if the problem persists, they could exchange the catheter.No further issues were reported.There was no report of delay in therapy.There was no report of patient complication, serious injury, or death.
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Search Alerts/Recalls
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