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Model Number 775100 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2018 |
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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reported the tubing of the enteral feeding set was properly installed without puncturing the bag and was tightly screwed.After a few minutes, the feeding formula was leaking on the pump without any alarm ringing.
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Manufacturer Narrative
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Submission date: 09/17/2018 an investigation was performed for the reported customer complaint: ¿the customer reported the tubing of the enteral feeding set was properly installed without puncturing the bag and was tightly screwed.After a few minutes, the feeding formula was leaking on the pump without any alarm ringing.¿ the device history record (dhr) for the reported lot number 180190317 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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