MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS
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Model Number BE-HLS 7050#HLS SET ADVANCED 7.0 |
Device Problem
Pressure Problem (3012)
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Patient Problems
Ischemia (1942); Low Oxygen Saturation (2477)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up medwatch will be submitted when additional information becomes available.
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Event Description
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Patient connected on a/v ecls procedure.With cardiohelp and hls 7050 ; after 20 mns : bad signs: the delta p was increasing, signs of desaturation of the patient, little signs of leg ischemia.They decided to change the pack hls with a new one.After less than 24 hours; same issues with the same patient.Nearly same signs, they decided to change the console with xenios one and xenios ecmo set.Since more than 24 hours , no issue was detected with xenios console.Complaint id: (b)(4).
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Event Description
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Complaint id: (b)(4).
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Manufacturer Narrative
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The hls module was investigated in the laboratory on 2020-01-17.Results: during the optical inspection of the hls oxygenator, a detached silicone seal was found on the pressure sensor (connector).During the leak test according to lv 201, a leak was detected at a connecting bridge of the pump to the oxygenator.The seals have not been mounted correctly.During functional testing with the cardiohelp, no pressures were detected.The most probable root cause is that the pressure sensor got wet due to the incorrectly mounted seals.Thus the failure could be confirmed.The occurrence rate is below the acceptance rate, thus no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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