BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number MMC96901L |
Device Problems
Filling Problem (1233); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that an unspecified number of solution administration sets underinfused while being used with an evo iq pump.It was stated that the flow rate of the pump was ¿over +/- 10%¿ and the intravenous fluid did not fully infuse at the end of the infusion.This was further described as ¿1000ml ns, 100ml/h, q10h, during end of infusion, 150ml was left.1.5 hours delayed, total 11.5 hours was requested to complete infuse¿.It was further reported that the tubing was flattened after 18 hours of infusion.This issue was noted during a patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a picture and companion sample were received for evaluation.Visual inspection to the companion sample and the photograph, did not identify any abnormalities that could have contributed to the reported condition.Functional testing were completed to the companion sample and the device performed according to product specifications.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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