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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC WITH BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC WITH BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be sumbitted when additional information becomes available.
 
Event Description
Hold for erika 08. 06 this complaint was created by maquet cardiopulmonary (b)(4) on behalf of (b)(6). Complaint originator: (b)(6). Name of preparer: (b)(6). E-mail of preparer: (b)(6). Reference #: (b)(4). Patient in ecmo reports an increase in the pressure differential, greater than 150 mmhg, a decrease in oxygenation is observed despite an increase in fi o2 and co2 retention despite an increase in gas flow, a membrane change is decided; which improves the differential of oxygenation pressures and co2 sweep. Paciente en ecmo se reporta aumento en el diferencial de presión, mayores a 150 mmhg, se observa disminución en la oxigenación a pesar de aumento en fi o2 y retención de co2 a pesar de aumento en el flujo de gas, se decide cambio membrana; con lo cual mejora el diferencial de presiones oxigenación y barrido de co2. Reporte de calidad (b)(4) a proveedor (b)(4) kit ecmo pediatrico quadrox be-hmod30000. Complaint id: (b)(4).
 
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Brand NameQUADROX-ID PEDIATRIC WITH BIOLINE COATING
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 Key10367236
MDR Text Key201878999
Report Number8010762-2020-00245
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K100278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2020
Device Model NumberBE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
Device Catalogue Number70104.7041
Device Lot Number70124698
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 Received08/28/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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