Model Number HMOD 70000-USA #SQUADROX-ID ADULT O.FILT |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2022 |
Event Type
malfunction
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Event Description
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The event occurred in the us.It was reported that a patient was on ecls support with a centrimag and a hmod 70000-usa #squadrox-id adult o.Filt.A leakage on the outlet connector was detected and it looked like a crack around it.No leakage was noticed during priming.The customer decided to exchange the oxygenator with another one.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 medwatch 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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There was a mistake in section h in "type of reportable event".There was no serious injury reported.The type of event has been corrected to "malfunction".
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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 event occurred in the us.It was reported that a patient was on ecls support with a centrimag and a hmod 70000-usa #squadrox-id adult o.Filt.A leakage on the outlet connector was detected and it looked like a crack around it.No leakage was noticed during priming.The customer decided to exchange the oxygenator with another one.No harm to any person has been reported.The affected hmod70000-usa #squadrox-id ad.O.Fil.With lot# 3000181778 was investigated in the getinge laboratory on 2022-02-08 with the following results: during the investigation of the oxygenator no abnormalities on the blood outlet connector could be detected.A leakage on the gas outlet connector could be confirmed during the tightness test on the blood side of the oxygenator.The probable root cause of the leakage at the gas outlet could be determined as a leak between the blood and the gas side inside the oxygenator, which was erroneously described as a leakage at the blood outlet connector by customer.The reported failure "leakage on the blood outlet connector" noticed by the customer, was caused by the leakage found at the gas outlet connector which allows small water drops flowing down at the housing and collecting at the blood outlet connector of the oxygenator.Based on the investigation results the reported failure could be confirmed.The production records of the affected hmod70000-usa #squadrox-id ad.O.Fil.With packaging lot 3000181778 were reviewed on 2022-02-08 and according to the final test results, the hmod70000-usa #squadrox-id ad.O.Fil.With lotnumber 3000181778 and serial number 4307 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.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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