Model Number IPN000320 |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2020 |
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 when the intra-aortic balloon pump (iabp) was in use the nurse stated that there were water droplets in the gas tubing.The condensation bottle was empty.They have noted this condensation for over 24 hour and noted water droplets in the gas tubing.As a result, the iabp was swapped to another iabp.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that when the intra-aortic balloon pump (iabp) was in use the nurse stated that there were water droplets in the gas tubing.The condensation bottle was empty.They have noted this condensation for over 24 hour and noted water droplets in the gas tubing.As a result, the iabp was swapped to another iabp.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).No iap part was returned to teleflex chelmsford for investigation.The reported complaint of "drain failure alarms" is not able to be confirmed.A teleflex service engineer serviced the pump and could not duplicate the problem.The pump passed functional checkout.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00151 (b)(4) as the report is related to the same patient.
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Search Alerts/Recalls
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