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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 BO-VKMO 71000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2024
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that a leak was detected at dial-lock connector (dialysis lock with valve) of oxygenator after the start of operation approximately one and half hour later.The failure was detected during treatment.However, blood dripped few drops and product was not required to change at the operation.The operation was completed without any problem.No harm or death to any person was reported.Complaint # (b)(4).
 
Manufacturer Narrative
It was reported that a leak was detected at dial-lock connector (dialysis lock with valve) of oxygenator after the start of operation approximately one and half hour later.The failure was detected during treatment.However, blood dripped few drops and product was not required to change at the operation.The operation was completed without any problem.No harm to any person has been reported.The sample was investigated at maquet cardiopulmonary gmbh laboratory on 2024-05-16.Visual inspection of the leaked area was performed and no abnormalities were observed.Further, the flow test and leak test were performed and passed.Based on the laboratory investigation results, the complaint could not be confirmed.The production history record (dhr) of the affected quadrox-i adult with lot # 3000317171 was reviewed on 2024-02-27.According to the dhr results, the product quadrox-i adult passed the defined manufacturing and final release specifications.The production history record (dhr) of the affected bo-vkmo 71000 with lot# 3000323425 was reviewed on 2024-04-16.According to the dhr result, the product bo-vkmo 71000 passed the defined manufacturing and final release specifications.Based on the investigation results, the cause of the leakage could be related with: the locking pin was possibly not centred and that result as leakage.Excessive pressure & flow rate applied during treatment.Exact root cause of the reported failure could not be determined.The customer will be informed about the results by getinge sales and service unit.The occurrence rate was calculated for the reported failure and product 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.
 
Event Description
Complaint #(b)(4).
 
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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 Key18746596
MDR Text Key335857124
Report Number8010762-2024-00095
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBO-VKMO 71000
Device Catalogue Number701067951
Device Lot Number3000323425
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received02/21/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2023
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Other;
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