BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306544 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
Underdose (2542)
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Event Date 05/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.(b)(6).Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that bd posiflush¿ normal saline syringe pump is not giving the correct volume.This was discovered during use.The following information was provided by the initial reporter: material no: 306544, batch no: unknown.It was reported that the pump is unable to detect the syringes and is not delivering the correct volume.Description of problem: these 3ml ns flushes (larger barrel than the previous 3ml ns flushes, which were long and skinny) are not recognized by our alaris iv pumps correctly, instead of detecting a 3ml syringe, the pump only detects it as a 10ml syringe.When these new flushes were placed in our store room, rns were instructed to just run it as a 10cc flush.If this is selected, the pump is unable to deliver the desired volume of flush to the patient (ie: enter to flush 1ml, only.6 is delivered).This negatively impacts our patients, especially the smallest babies.If the whole flush isn't delivered, then medication is still in the iv line and the patient does not receive their entire dose.Some nurses- myself included- are working around this issue by using the sterile 10cc ns flushes that the pumps recognize and deliver the correct volume, but cost more.This has been an ongoing issue since the product was replaced.
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Event Description
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It was reported that bd posiflush¿ normal saline syringe pump is not giving the correct volume.This was discovered during use.The following information was provided by the initial reporter: material no: 306544 batch no: unknown it was reported that the pump is unable to detect the syringes and is not delivering the correct volume.Description of problem: these 3ml ns flushes (larger barrel than the previous 3ml ns flushes, which were long and skinny) are not recognized by our alaris iv pumps correctly, instead of detecting a 3ml syringe, the pump only detects it as a 10ml syringe.When these new flushes were placed in our store room, rns were instructed to just run it as a 10cc flush.If this is selected, the pump is unable to deliver the desired volume of flush to the patient (ie: enter to flush 1ml, only.6 is delivered).This negatively impacts our patients, especially the smallest babies.If the whole flush isn't delivered, then medication is still in the iv line and the patient does not receive their entire dose.Some nurses- myself included- are working around this issue by using the sterile 10cc ns flushes that the pumps recognize and deliver the correct volume, but cost more.This has been an ongoing issue since the product was replaced.
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Manufacturer Narrative
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Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
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