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Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that during connection, the pump alarmed completion approximately 11.5 hours early.The pump was programmed at 144 ml at 1.5 ml/hr.When the pump was disconnected, 126.75 ml infused and 17.3 ml remained, however the bag was emptied.No patient injury was reported.
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Manufacturer Narrative
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Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: model number, catalog number, lot number, expiration date, udi, g5, and h4 are unknown.
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Manufacturer Narrative
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Other, other text: d3, g1,2 email is: (b)(4).One device was returned for evaluation.Visual inspection revealed no physical damage.Functional testing was performed but the reported issue could not be replicated or confirmed; no discrepancies were detected.The root cause could not be determined.No further action was taken.No lot number was provided; therefore, a history record review could not be conducted.
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Search Alerts/Recalls
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