Model Number P10P-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 05/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The excor blood pump, s/n (b)(4) on the patient at the time of the event was in use from (b)(6) 2022 (6 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
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Event Description
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The site reported that they had experienced issues with pump fill despite manipulation of the inflow cannula and parameters.The site stated that they observed a consistent concave dimple in the middle of the membrane during fill.It was decided by the site that the pump would be switched out in the event this was a membrane issue.Of note, bhi was not contacted before or during the event but was contacted after the event had occurred (b)(6) 2022).The pump change occurred without untoward effect to the patient.
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Manufacturer Narrative
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No abnormalities were observed upon initial examination of the returned pump.The blood pump was tested for functional performance using the driving unit settings at the time of the event reported to us by the site and repeated the functional test using different parameters defined in internal procedures.The pump performance was within specification for both the testing parameters defined by berlin heart and the clinic's settings.The pump showed complete filling and ejection.For further analysis the blood pump was disassembled, and the membrane layers were examined individually.All three membrane layers were intact and show no defect.The dispersion of graphite was uniform and gapless.The stabilization ring was not damaged.No defect nor any functional impairment was detected.The blood pump met its specification.The cause for the uniform concave dimple in the center of the membrane observed by the clinic was not able to be determined.
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Search Alerts/Recalls
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