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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR WITH INTEGRATED HEAT EXCHANGER OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH OXYGENATOR WITH INTEGRATED HEAT EXCHANGER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HMO 71000 #SQUADROX-I ADULT + FILTER
Device Problems Coagulation in Device or Device Ingredient (1096); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
The information provided to the manufacturer is as follows (no further information provided up to date): hmo71000: it became oxygenated from the middle. After replacing the circuit, the operation is finished. The product cannot be collected due to infectious disease patients. (b)(4).
 
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Brand NameOXYGENATOR WITH INTEGRATED HEAT EXCHANGER
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key9645916
MDR Text Key195528320
Report Number8010762-2020-00040
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K150267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model NumberHMO 71000 #SQUADROX-I ADULT + FILTER
Device Catalogue Number701067821
Device Lot Number70131620
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 Received01/30/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2019
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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