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Model Number 383400 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
Discomfort (2330)
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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 while using an unknown pump with an unknown serial number the pump was started per usual usage for a feeding, and the distal line was occluded.The distal occlusion alarm failed resulting in a spillage of formula, this is not a first-time occurrence.The occurrence rate for this is all the time if the distal end is occluded by clamping and when tested in a test environment it occurs at least 75% of the time.No labs or tests can be collected aside from measuring flow from the pump to a graduated cylinder and examining the wild inaccuracy in the pump's delivery 25% greater or lesser deviation from set infusion.Additional information was received and stated that the volume to be infused (vtbi) used was 1000ml; rate set to 120-150 ml and actual volume delivered is unknown; nutrition used was 50/50 mix of nutren 2.0 with water.The customer further stated the device caused minor discomfort, but no injury resulted.
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Manufacturer Narrative
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Based on the serial number provided by the customer, the product code has been obtained.Please see section b5 (describe event or problem); section d1/d2 (brand name, product code); d4 (model number, unique identifier (udi) number) for the corrected data.
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Event Description
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The customer reported that the pump was started per usual usage for a feeding, and the distal line was occluded.The distal occlusion alarm failed resulting in a spillage of formula, this is not a first-time occurrence.The occurrence rate for this is all the time if the distal end is occluded by clamping and when tested in a test environment it occurs at least 75% of the time.No labs or tests can be collected aside from measuring flow from the pump to a graduated cylinder and examining the wild inaccuracy in the pump's delivery 25% greater or lesser deviation from set infusion.Additional information was received and stated that the volume to be infused (vtbi) used was 1000ml; rate set to 120-150 ml and actual volume delivered is unknown; nutrition used was 50/50 mix of nutren 2.0 with water.The customer further stated the device caused minor discomfort, but no injury resulted.
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Search Alerts/Recalls
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