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Catalog Number ASKU |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 one link under infused while connected to a large volume infusor.It was further reported, after the expected infusion time of 96 hours of infusion, ¿a lot of drug¿ remained in the device.The device was filled with 5-fluorouracil and infused via a peripherally inserted central catheter (picc).This was observed after use of the device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, a photograph was provided for evaluation.Visual inspection of the photograph revealed that there was a device attached to the infusor; however, it was not possible to determine if the device was a one-link due to the quality of the photograph.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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