Model Number IPN000255 |
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 02/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Reference mfr rpt# 3010532612-2022-00094 as it involved the same patient.There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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It was reported that high pressure alarms occurred intermittently before blood was noticed coming down the helium driveline.As a result, the catheter was removed.It was noted that the patient is stable on ecmo.
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Event Description
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It was reported that high pressure alarms occurred intermittently before blood was noticed coming down the helium driveline.As a result, the catheter was removed.It was noted that the patient is stable on ecmo.
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Manufacturer Narrative
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(b)(4).Reference mfr rpt# 3010532612-2022-00094 as it involved the same patient.The product was not returned for investigation.The reported complaint of iab blood in helium pathway is confirmed based on the customer photo/video provided with the complaint report.The photo/video showed blood present in the helium pathway.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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Search Alerts/Recalls
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