Catalog Number CARDIAC UNKNOWN |
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 07/12/2021 |
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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Customer reported that the balloon burst from a previous patient.The presence of blood on the balloon connector and internal parts of the pump was found.Patient information is unknown at this time.There was no report of complication, serious injury, or death to the patient.
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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.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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Customer reported that the balloon burst from a previous patient.The presence of blood on the balloon connector and internal parts of the pump was found.Patient information is unknown at this time.There was no report of complication, serious injury, or death to the patient.
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Search Alerts/Recalls
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