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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 03/04/2022
Event Type  malfunction  
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
The event occurred in the us.It was reported that a hmod 70000-usa #squadrox-id adult o.Filt was placed on a patient and a leakage of clear fluid from the gas exhaust ports was noticed.Not blood only clear fluid was leaking.The customer suspected it is heater/cooler fluid.The oxygenator was replaced with another one during use.No harm to any person has been reported.Complaint id: (b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The event occurred in the us.It was reported that a hmod 70000-usa #squadrox-id adult o.Filt was placed on a patient and a leakage of clear fluid from the gas exhaust ports was noticed.Not blood only clear fluid was leaking.The customer suspected it is heater/cooler fluid.The oxygenator was replaced with another one during use.No harm to any person has been reported.The affected hmod 70000-usa #squadrox-id adult o.Filt was investigated in the getinge laboratory on 2022-04-27 with the following results: a tightness test of the water, gas and blood side was performed and no abnormalities or leakage are detected.No other abnormalities on the affected oxygenator were noticed.Based on the investigation results the reported failure "leakage gas outlet" could not be confirmed.However, the reported failure "leakage gas outlet" can be linked to the following most possible root causes according to the quadrox-i small adult/adult, quadrox-id adult risk management file: - broken or distorted diffusive fibers.The production records of the affected hmod 70000-usa #squadrox-id adult o.Filt with lot#3000172920 were reviewed on 2022-04-27.According to the final test results, the hmod 70000-usa #squadrox-id adult o.Filt with lot#300020230 and serial number (b)(6) passed the tests as per specifications.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
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key13692505
MDR Text Key286749584
Report Number8010762-2022-00072
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
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2023
Device Model NumberHMOD 70000-USA #SQUADROX-ID ADULT O.FILT
Device Catalogue Number701067840
Device Lot Number3000172920
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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