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 11/17/2021 |
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 received persistent helium loss alarms.The staff had checked all connections, exchanged the pump, and there was no blood in the tubing.The catheter failed a leak test.As a result, the iab was removed without difficulty, and the patient was stable off-pump, so a second iab was not inserted.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 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.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 staff received persistent helium loss alarms.The staff had checked all connections, exchanged the pump, and there was no blood in the tubing.The catheter failed a leak test.As a result, the iab was removed without difficulty, and the patient was stable off-pump, so a second iab was not inserted.There was no report of patient complications, serious injury or death.
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