Model Number IPN924915 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Event Description
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Reported as "blood coming out of the trunk cable connector during flush process, suggesting a broken seal in that transducer assembly/membrane where the cable connects".No medical intervention necessary.No patient injury or consequence.Patient condition reported as "fine".Associated mdr 3010532612-2022-00577.
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Manufacturer Narrative
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Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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Reported as "blood coming out of the trunk cable connector during flush process, suggesting a broken seal in that transducer assembly/membrane where the cable connects".No medical intervention necessary.No patient injury or consequence.Patient condition reported as "fine".Associated mdr 3010532612-2022-00577.
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Search Alerts/Recalls
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