Catalog Number IAP-0500 |
Device Problems
Mechanical Jam (2983); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see mdr# 3010532612-2019-00393 and (b)(4) as the report is related to the same device.
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Event Description
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It was reported the intra-aortic balloon pump (iabp) had a purge failure.As a result, the iabp was swapped out.The field service engineer (fse) was called in to service the iabp.Upon servicing the fse found that fill valve #2 was not opening as the helium was escaping through the 1 psi relief valve when the iabp attempted to fill.As a result, the pcs assembly was replaced.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).Two complaints were opened in error for this reported complaint.The device was returned to teleflex for investigation.One part was returned for investigation for both complaints, and that part's failures can be the cause of both the complaints.The reported complaint was investigated and identified and will be captured under complaint mdr #3010532612-2019-00393, teleflex conformation no.(b)(4).Complaint mdr initial #, teleflex confirmation no.(b)(4) will be closed/canceled.Other remarks: see mdr# 3010532612-2019-00393 and tc (b)(4) as the report is related to the same device.
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Event Description
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It was reported the intra-aortic balloon pump (iabp) had a purge failure.As a result, the iabp was swapped out.The field service engineer (fse) was called in to service the iabp.Upon servicing the fse found that fill valve #2 was not opening as the helium was escaping through the 1 psi relief valve when the iabp attempted to fill.As a result, the pcs assembly was replaced.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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