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

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

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a pediatric patient was connected to a quadrox-id pedi. The blood pressure and lpm value of the patient suddenly dropped after approximately 30 h. The oxygenator was clogged and did not work anymore. The oxygenator was replaced. No harm to patient reported. Complaint id: (b)(4).

• Brand Name: QUADROX-ID PÄD.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; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12166042
• MDR Text Key: 261459878
• Report Number: 8010762-2021-00396
• 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
• 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: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 701047041
• Device Lot Number: 70145550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Type of Device Usage