Catalog Number 300865 |
Device Problems
Leak/Splash (1354); Failure to Deliver (2338)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 12/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced difficult plunger movement and was involved with a serious injury -hypotension.The following information was provided by the initial reporter: sku 187508 syringe 50ml luer lock bd n300865 1 x 60.Syringe infusion pumps ¿ drug delivery failure.It became most notable during phase 1 of the pandemic.We had changed over from old pumps to new pumps, and we initially thought it was a programming issue.To alleviate it we increased the pump occlusion pressure but this did not help.We took syringe samples to our physics lab which showed a high pressure across the system.It convincingly became a syringe issue when we started to get the same issue in theatre using the old pumps.Any harm on a patient? -thankfully no long-term harm but several patients had significant hypotensive episodes when noradrenaline failed.
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Manufacturer Narrative
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H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.
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Event Description
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It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced difficult plunger movement and was involved with a serious injury -hypotension.The following information was provided by the initial reporter: sku 187508, syringe 50ml luer lock bd n300865 1 x 60.Syringe infusion pumps ¿ drug delivery failure.It became most notable during phase 1 of the pandemic.We had changed over from old pumps to new pumps, and we initially thought it was a programming issue.To alleviate it we increased the pump occlusion pressure but this did not help.We took syringe samples to our physics lab which showed a high pressure across the system.It convincingly became a syringe issue when we started to get the same issue in theatre using the old pumps.Any harm on a patient? -thankfully no long-term harm but several patients had significant hypotensive episodes when noradrenaline failed.
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Search Alerts/Recalls
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