Model Number 8100 |
Device Problems
Inaccurate Delivery (2339); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Confusion/ Disorientation (2553)
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Event Date 10/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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Bd technical support troubleshoot with customer over the phone.The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
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Event Description
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It was reported that a patient received a manually programmed bolus of 8000 units heparin with an intended continuous rate of 18ml / hour at 23:00.The next morning the patient became "unstable" and exhibited altered mental status.Partial thromboplastin time went from 77 to 139.The infusion was stopped, and the patient was transferred to the critical care unit.The patient received a ct scan and continued to be "unstable".Although multiple attempts were made, no additional information was made available.
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Manufacturer Narrative
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Omit : c20 - no findings available, d15 - cause not established.Correction: medical device serial #, device manufacture date.Additional information : imdrf annex a, g, b, c, d codes and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.It was determined through investigation of the returned devices that the initially reported suspect device with serial number# (b)(6) is a concomitant and this file has captured the correct suspect device with serial number#9877076 as per investigation report.
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Event Description
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It was reported that a patient received a manually programmed bolus of 8000 units heparin with an intended continuous rate of 18ml / hour at 23:00.The next morning the patient became "unstable" and exhibited altered mental status.Partial thromboplastin time went from 77 to 139.The infusion was stopped, and the patient was transferred to the critical care unit.The patient received a ct scan and continued to be "unstable".Although multiple attempts were made, no additional information was made available.
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Search Alerts/Recalls
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