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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HMOD 70000-USA #SQUADROX-ID ADULT O.FILT
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2022
Event Type  malfunction  
Event Description
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).
 
Manufacturer Narrative
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.
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
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".
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
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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Brand Name
OXYGENATOR
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key13235394
MDR Text Key283663021
Report Number8010762-2022-00004
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/08/2023
Device Model NumberHMOD 70000-USA #SQUADROX-ID ADULT O.FILT
Device Catalogue Number701067840
Device Lot Number3000181778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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