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Catalog Number 2C4063K |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter address: (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 a large volume folfusor underinfused medication.The balloon in the plastic housing was not completely infused.The issue was identified during patient infusion.The patient disconnected the device, the bung/blue connector on the extension site was cleaned thoroughly with an alcohol swab.When the patient flushed the line with 0.9% nacl, resistance was felt.Blood draw back working from picc (peripherally inserted central catheter) line.The extension line was removed and a new extension line was primed and attached, flushed again and worked well.The device had been filled with piperacillin/ tazobactam 18000mg in 230ml sodium chloride 0.9%.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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H4: the lot was manufactured from july 18, 2023 to july 20, 2023.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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