Model Number PCA TUBING |
Device Problem
False Alarm (1013)
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Patient Problems
Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)
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Event Date 05/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: (2) anti-syphon valves; monoject 60ml syringe.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.However the event was reported to have occurred in the pediatric department therefore it is presumed the patient was a pediatric patient.
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Event Description
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It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during midazolam 55mg/55ml (1mg/ml).The alarm issues started when bd performed a product change to the 60ml syringe which caused the customer to change to a non-bd 60ml syringe.The cardiovascular unit pca tubing set-up includes (2) anti-siphon valves.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate with the non-bd 60ml syringe in use.The patient required additional medication boluses in order to reduce agitation and pain.It was further stated that the device experienced approximately 10 nuisance alarms.
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Event Description
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It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during midazolam 55mg/55ml (1mg/ml).The alarm issues started when bd performed a product change to the 60ml syringe which caused the customer to change to a non-bd 60ml syringe.The cardiovascular unit pca tubing set-up includes (2) anti-siphon valves.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate with the non-bd 60ml syringe in use.The patient required additional medication boluses in order to reduce agitation and pain.It was further stated that the device experienced approximately 10 nuisance alarms.
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Manufacturer Narrative
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No product will be returned per customer.The customer complaint of tubing set caused pump interaction issues could not be confirmed due to the product not being returned for failure investigation.The customer provided a photo of a 55ml syringe with a yellow note labeled with its event date of (b)(6) 2020 when incident occurred.The root cause of this failure was not identified as no product was returned.
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Manufacturer Narrative
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The customer¿s report of pca syringe module continuously alarmed for ¿syringe patient pressure¿ (occlusion) was replicated when the non-bd (monoject) syringe was used during functional testing using customer designated settings.The non-bd syringe was visually inspected for damage.No damage or other abnormalities were observed.The suspect pca pump tubing was not received from the customer for inspection and testing.Functional testing (using non-bd syringe) observed occlusions at lower pressure, more noticeably at medium settings, and no occlusions at high pressure when compared to a bd syringe.The above functional testing was repeated using a bd 60ml syringe.No occlusion alarms were noted by the device during infusion using the three occlusion pressure settings.The root cause of the syringe patient pressure (occlusion) alarms was not determined.The device history record for pca pump tubing lot unknown could not be conducted because the model and lot information was not provided diameter.
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Event Description
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It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during midazolam 55mg/55ml (1mg/ml).The alarm issues started when bd performed a product change to the 60ml syringe which caused the customer to change to a non-bd 60ml syringe.The cardiovascular unit pca tubing set-up includes (2) anti-siphon valves.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate with the non-bd 60ml syringe in use.The patient required additional medication boluses in order to reduce agitation and pain.It was further stated that the device experienced approximately 10 nuisance alarms.
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Search Alerts/Recalls
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