MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PÄD OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Further patient data and perfusion protocol were requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the oxygenator clotted and the oxygenation decreased during treatment. No harm to patient reported. Complaint id: (b)(4).

• Brand Name: QUADROX-ID PÄD
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12337816
• MDR Text Key: 267109650
• Report Number: 8010762-2021-00456
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 701047041
• Device Lot Number: 70143295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes

Type of Device Usage