MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PAD.O.FILT OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT

Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

Return of product and patient data were requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that they needed to change out emergently (within 24-36 hours) a quadrox-id pediatric due to high transmembrane pressures that indicate that there is a large amount of blood clot present inside the oxygenator. When this happens it affected the ability to maintain ecmo flow to the patient. Complaint id: (b)(4).

• Brand Name: QUADROX-ID PAD.O.FILT
• 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; kehler strasse 31; hechingen 76437 ; GM 76437
• Manufacturer Contact: neue rottenburger strasse 37; kehler strasse 31; hechingen 76437 ; 4972229321
• MDR Report Key: 11435335
• MDR Text Key: 242778657
• Report Number: 8010762-2021-00152
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
• Device Catalogue Number: 70105.0330
• 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: 07/06/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial