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Model Number P15P-001 |
Device Problem
Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2020 until (b)(6) 2020(10 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.The blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons.The entire membrane consists of an air-side layer, a middle layer and a blood-side layer.In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers.A detailed investigation report will be provided as soon as if it available.
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Event Description
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Berlin heart inc.Was informed by the site about incomplete fill and ejection of the excor blood pump of a patient supported in the lvad configuration.The affected blood pump was exchanged in the clinic by trained professionals without complications.The patient was not affected by this incident and is doing well.
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Manufacturer Narrative
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During initial visual examination of the returned blood pump, an air cushion could be detected between the membrane layers.For further analysis the pump was disassembled and the membrane layers were individually examined.A leakage was detected in the air-side layer along the rolling radius of the stabilization ring.Furthermore, graphite agglomerates were found between the membranes.The middle layer and the blood-side layer of the triple layer membrane were found to be intact.The thickness of the defective membrane layer, and the one adjacent was re-measured at defined points.The thickness of the individual layers at all defined points and in the area around the leakage was found to be within specification at the time of the re-measurement.The cause of the failure was most likely the graphite particles that formed due to abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer.As a result of this defect, air got in between the membrane layers and formed an air cushion, causing the reduced pump performance (incomplete filling and emptying).
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Search Alerts/Recalls
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