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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 VKMO 78000 #SQUADROX-I HMO 70000+VHK7000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing. A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that there was leakage (bleeding) at product. There is no indication of actual for harm or death. Complaint: #(b)(4).
 
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Brand NameOXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key12559862
MDR Text Key274222306
Report Number8010762-2021-00535
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVKMO 78000 #SQUADROX-I HMO 70000+VHK7000
Device Catalogue Number70106.7941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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