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).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a patient on ecmo had an increase in the differential pressure, greater than 150mmhg, and a decrease in oxygenation despite an increase in fio2 and co2.The device history record of the affected product was reviewed and no references were found, which are indicating a nonconformance of the product in question.The reported failure is a result of coagulation of the membrane.Due to the impaired blood flow and extension of the diffusion path the oxygenation performance is decreased.According to the risk assessment (quadrox-id pediatric dms #1462367 v18) following causes can lead to coagulation: - debris formation (clogging) at the inlet fiber due to high pump speed; - hemostasis; - insufficient anticoagulation; - drugs administration (e.G.Propofol); - air in circuit.Thus the failure could be confirmed.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• 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
• 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
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• 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
• Date Manufacturer Received: 08/28/2020
• Patient Sequence Number: 1