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Model Number P25P-001X01 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2020 |
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 to (b)(6) 2020 (98 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 it is available.
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Event Description
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Berlin heart inc.Was informed by the clinic about incomplete ejecting of the excor blood pump of a patient supported in the lvad configuration.Videos were sent by the site, and berlin heart inc.Recommended an exchange of the blood pump.The affected blood pump was exchanged in the clinic by trained professionals without complications and the patient 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 was detected between membrane layers.The pump was then disassembled for further testing and the membrane layers were individually examined.In the air-side layer and the middle layer of the triple layer membrane a leakage was detected each.Both leakages were located along the rolling radius of the stabilization ring.The blood-side layer was found to be intact.Graphite agglomerates were detected between the membrane layers.The thickness of all three membrane layers was re-measured at the defined points.The thickness of the individual layers at all defined points was found to be within specification at the time of the re-measurement.In the area around the leakages, the thickness profile of the air-side layer and the middle layer was also found to be within specification at the time of the re-measurement.The cause of the leakages in the air-side layer and the middle layer was most likely graphite abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer and the middle layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion in the membrane interstices, causing the reduced pump performance (incomplete filling and emptying).
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Search Alerts/Recalls
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