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Model Number P15P-001 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2021 |
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 (145 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 was contacted by the clinic to report that the lvad pump on a patient supported in the lvad configuration was not ejecting.The site noticed the change in membrane function due to the ikus alarm "check left pump/drive line".The site also notified berlin heart that they had changed over to the hand pump prior to calling berlin heart clincal affairs.Berlin heart recommended an immediate exchange of the blood pump due to a suspected defect of the airside layer of the triple layer membrane.The affected blood pump was exchanged in the clinic by trained personnel.The exchange was performed 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 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 abrasion was detected 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 leakage in the air-side layer was most likely a graphite abrasion between the membrane layers.This caused increased friction at some points, which finally led to the defect in the air-side layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion, causing the reduced pump performance (incomplete fill and ejection).
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Search Alerts/Recalls
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