Model Number 8100 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/30/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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.H3 other text : device was not returned to manufacturing facility.
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Event Description
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It was reported that although the pump module channel was on, the blinatumomab medication did not infuse for approximately four (4) hours.The pump was stopped on 30jan2024 at 06:57 after an air-in-line alarmed.There was patient involvement, but outcome is unknown.Although requested no additional information will be provided by the customer, no devices will be returned.
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Manufacturer Narrative
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Additional information: imdrf annex b code 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.
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Event Description
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It was reported that although the pump module channel was on, the blinatumomab medication did not infuse for approximately four (4) hours.The pump was stopped on (b)(6) 2024 at 06:57 after an air-in-line alarmed.There was patient involvement, but outcome is unknown.Although requested no additional information will be provided by the customer, no devices will be returned.
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Search Alerts/Recalls
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