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

Model Number QUADROX-ID SMALL ADULT/ADULT

Device Problem Improper Chemical Reaction (2952)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Further product 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 during patient treatment with a quadrox-id the co2 removal rate was lower than expected.No harm reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that during patient treatment with a quadrox-id the co2 removal rate was low.Oxygenation was in range.The customer provided blood gas values pre and post oxygenator.It could be confirmed that the p-co2 values did increased (70 to 72 mmhg).The p-o2 value was in normal range (57 to 490 mmhg) no further data or information was provided by the customer and the oxygenator was not available for technical investigation.Based on the provided data no exact root cause could be determined: however following probable root causes were identified in the quadrox-id risk assessment: -insufficient flushing -leaks or damage of oxygenator -insufficient gas to blood ratio -coagulation in circuit based on the investigation results no product related malfunction 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.4115.

Event Description

Complaint id:(b)(4).

• Brand Name: QUADROX-ID
• 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: 12330848
• MDR Text Key: 266862946
• Report Number: 8010762-2021-00449
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150267
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-ID SMALL ADULT/ADULT
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1