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

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).

• Brand Name: QUADROX-ID PEDIATRIC WITH BIOLINE COATING
• Type of Device: OXYGENATOR, 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 Key: 10367236
• MDR Text Key: 201878999
• Report Number: 8010762-2020-00245
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• 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 Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/12/2020
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 70104.7041
• Device Lot Number: 70124698
• 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 Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial