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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 HQV 128702#PACK VKMO 71000
Device Problem Output Problem (3005)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up mdr will be submitted when further information becomes available.
 
Event Description
Description sent by the perfusionist: "the failure occurred 100 minutes after cec, when we were finished and we were going to start the pump output, so there has been no problem with the patient, since we left quickly, and the patient has woken up and evolved without problems today. Male, (b)(6) years old, weight (b)(6), size 1. 67cm, bsa 1. 99m2. It was at a pump flow of 3800, with 32 degrees of temperature, with a flow of gases of 1. 2 and a fio2 of 50% and the gasometry was: ph7. 32, po2 156, pco2 42, and so2 98. 7%. Suddenly the blood became very dark and i took out others, having previously risen, the gas flow to 3l and the fio2 to 60%, and the result was: ph 7. 26, po2 51. 7, pco2 53. 3, so2 84. 4%. I went back up to fio2 of 100% and 4l and i left cec. " complaint: (b)(4).
 
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Brand NameOXYGENATOR
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 Key11284121
MDR Text Key242862241
Report Number8010762-2021-00098
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeSP
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 04/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2022
Device Model NumberHQV 128702#PACK VKMO 71000
Device Catalogue Number70107.4266
Device Lot Number92297607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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