Model Number 8110 |
Device Problems
Break (1069); Contamination (1120); Insufficient Flow or Under Infusion (2182)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/31/2024 |
Event Type
malfunction
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Event Description
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It was reported that the device was programmed with inv zz06 for duration of 120 minutes.However the infusion ended slower than intended.There was patient involvement however outcome is unknown.
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Manufacturer Narrative
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A follow up report will be submitted once the failure investigation 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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Manufacturer Narrative
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Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available, 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.H3 other text : not applicable.Device evaluated by bd.
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Event Description
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It was reported that the device was programmed with inv zz06 for duration of 120 minutes.However the infusion ended slower than intended.There was patient involvement however outcome is unknown.
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Search Alerts/Recalls
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