Catalog Number AI-07155-IK |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2023 |
Event Type
malfunction
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Event Description
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The report states that the "seal on sheath is leaking, back flow of blood and fluid into sterile wire cover.Unable to infuse vasopr essors/lifesaving medication through side arm because leaking up into sterile protector.Unable to remove pacer wire".Further information received states that the issue was resolved by using peripheral iv's instead.A new catheter was not inserted.The pacing cat heter was removed normally when no longer needed, it was not difficult to remove.No patient harm or injury.The patient status is reported as "stable".
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).The reported complaint that the "seal on sheath is leaking, back flow of blood and fluid into sterile wire cover" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that the "seal on sheath is leaking, back flow of blood and fluid into sterile wire cover.Unable to infuse vasopr essors/lifesaving medication through side arm because leaking up into sterile protector.Unable to remove pacer wire".Further information received states that the issue was resolved by using peripheral iv's instead.A new catheter was not inserted.The pacing cat heter was removed normally when no longer needed, it was not difficult to remove.No patient harm or injury.The patient status is reported as "stable".
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Search Alerts/Recalls
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