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 07/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that the staff called for help with persistent high-pressure alarms.The staff noted that there were specks of blood in the driveline tubing close to the patient.As a result, the intra-aortic balloon (iab) was removed and a new one was inserted at the same insertion site.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 blood in helium pathway 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.
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Event Description
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It was reported that the staff called for help with persistent high-pressure alarms.The staff noted that there were specks of blood in the driveline tubing close to the patient.As a result, the intra-aortic balloon (iab) was removed and a new one was inserted at the same insertion site.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway 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 staff called for help with persistent high-pressure alarms.The staff noted that there were specks of blood in the driveline tubing close to the patient.As a result, the intra-aortic balloon (iab) was removed and a new one was inserted at the same insertion site.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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