Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0 |
Device Problems
Contamination (1120); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2023 |
Event Type
malfunction
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Event Description
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The event occurred in hong kong.It was reported that a malfunction of the arterial pressure sensor was suspected during patient treatment.No clot was found on the oxygenator of the hls set and the flow was able to reach the target value.No harm to any person has been reported.Complaint id: (b)(4).
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Manufacturer Narrative
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The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.
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Event Description
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Complaint id# (b)(4).
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Manufacturer Narrative
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It was reported that there was a reading failure of the arterial pressure.The failure occurred during treatment.No clot was found on the oxygenator of the hls set and the flow was able to reach the target value.The affected hls set was investigated by the getinge laboratory on 2023-06-21 with following conclusion: during visual investigation it was confirmed that both cable ties on the blood inlet were very loose.The arterial pressure sensor was not working during technical investigation.The most probable root cause is a faulty solder joint.The production records of the affected #shls module advanced adult were reviewed on 2023-06-12 for the reported failure.According to the final test results, the #shls module advanced adult passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "p-art wrong reading" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Search Alerts/Recalls
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