Model Number BE-HLS 7050#HLS SET ADVANCED 7.0 |
Device Problem
No Device Output (1435)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/23/2019 |
Event Type
malfunction
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Event Description
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They reported that the internal pressures on the hls set are completely out of range.They jump from very high values to low values.Pressure cable was changed out, but no effect.Re-calibrating the pressures also did not help.Patient was on the device.No harm was done.New information was received on (b)(6) 2019: they changed cables, hardware etc.But the error still occurred.Thus the set was replaced during therapy.Internal ref.# (b)(4), onesupport # (b)(4).
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Manufacturer Narrative
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Maquet cardiopulmonary gmbh requested the affected product for return on 2019-09-26.Sample received on 2019-10-07.The returned product was investigated in the laboratory of the manufacturer on 2019-11-21.A hls module advanced 7.0 was returned.The sample was cleaned with sodium hypochlorite.The protective cover of the pump was removed.The pven showed no abnormalities.On the pint (delta p) sensor the adhesive as well as the adhesive membrane dissolved.The adhesive membrane is yellowish discoloured (got wet by priming solution).On the part sensor the adhesive has also dissolved and the adhesive membrane is yellowish discoloured.The module was connected to the cardiohelp.All pressure values were stable.Short time (approx.6 min) later the sensors part and delta p failed to work.Thus the reported failure could be confirmed.The most probable root cause is that the sensors became wet (see the yellow discoloration) and caused the sensors to malfunction.The device was directly involved in the reported incident and was used for treatment of the patient when the event occurred.The occurrence rate regarding the above complaint 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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Event Description
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Internal ref.# (b)(4), onesupport # (b)(4).
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Search Alerts/Recalls
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