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Model Number 383400 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported that the device's flow was not conforming.Additional information was provided stating that the issue happened during reconditioning test.The device flowed faster than the set rate.
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Manufacturer Narrative
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The service history record was reviewed and indicated that this is the first time that this kangaroo joey enteral feeding pump has been returned to the service center.The pump was decontaminated with an isopropyl alcohol wipe and an evaluation of the pump was performed.The unit was tested, and the reported issue could not be confirmed at this time.However, the software, battery, and overlay were found to be old and were replaced for this reason.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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