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Model Number 673662 |
Device Problems
Obstruction of Flow (2423); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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Event Description
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The customer reported that the formula was not passing through the line and was bubbling despite priming the pump.When using another bag there was no problem.Patient injury/harm was reported as unknown.Additional information provided by the customer stated that when priming the pump and pressing run, the pump gave the error of "feeding error" after a few minutes.When checking the line, there were large bubbles and spaces where the formula was not flowing despite not being obstructed per observation.The pump was re-primed and within minutes gave the error again.
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Manufacturer Narrative
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Correction: the customer reported the following potential/possible lot numbers: 192450157, 201250133, 192800057, 191890048, 191860080, 192240334, 192240333.Device code 2423, obstruction of flow, was absent from initial report.Section h6 has been updated accordingly.Lot number reported in initial report has been corrected from 19240157 to unk.Section d4 has been updated accordingly.
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Search Alerts/Recalls
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