BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES, 10ML, IN/OUT Ø6MM; VENTRICULAR ASSIST DEVICE
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Model Number P10P-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 11/27/2019 |
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) 2019 until (b)(6) 2019 (90 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.Initial visual inspection of the returned blood pump did not reveal any defects.The investigation of the affected blood pump is currently ongoing and a detailed report will be submitted upon completion of the analysis.
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Event Description
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Berlin heart was contacted by the clinic to report a suspected reduced function of an excor blood pump of a patient supported in the lvad configuration.Berlin heart recommended to exchange the affected blood pump.The blood pump was exchanged by trained professionals at the clinic on (b)(6) 2019.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 was detected between membrane layers.The blood pump was then tested for functional performance, where it did not reach its required functional performance, confirming the customer complaint.In the test contact between the blood-side layer and the pump housing could not be reproduced.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 leakages were detected.The leakages in the air-side layer were located along the rolling radius of the stabilization ring.The leakage in the middle layer was located near the center.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.The cause of the leakages in the air-side layer and the middle layer was most likely the graphite particles that formed due to an 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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