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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH OYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BO-HQV 129000
Device Problems Output Problem (3005); Pressure Problem (3012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up mdr will be submitted when further information becomes available. The sample has been requested but not received yet.
 
Event Description
Since the beginning of the ecc, the oxygenator module showed high delta pressure between inlet and outlet (500 mmhg in and 180 mmhg out). Shortly after the start (+/- 5 minutes), the whole circuit was replaced with a new one. Complaint # (b)(4).
 
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Brand NameOYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
kehler strasse 31
hechingen 76437
GM 76437
Manufacturer Contact
neue rottenburger strasse 37
kehler strasse 31
hechingen 76437
4972229321
MDR Report Key11320614
MDR Text Key231563823
Report Number8010762-2021-00105
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBO-HQV 129000
Device Catalogue Number70107.4294
Device Lot Number92309905
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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