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

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Improper Chemical Reaction (2952)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

The oxygenator and involved centrifugal pump was requested for investigation.In addition patient and perfusion data was requested but is still pending.A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that a quadrox-id needed to be replaced during treatment due to failing performance.No harm to patient reported.Complaint id:(b)(4).

Manufacturer Narrative

It was reported that a quadrox-id needed to be replaced during treatment due to failing performance.No further information of the patient or perfusion was received.Further return of the involved products was not available.With reference to the quadrox-id risk assessment following probable root causes were determined: air remains in or enters the circuit.Inappropriately low, or no blood flow, in the circuit.Improper hemostasis.Too low anticoagulation.Too low act level, effect of heparin is too limited.Protamine sulfate enters the circuit.Administration of congealable substances (such as platelets) or pro-coagulant medications.(consumption) coagulopathy.The production records of the affected quadrox module were reviewed on 2022-03-30.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results no product related malfunction could be confirmed.The occurrence rate was calculated for the reported issue 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.H3 other text : 4114.

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: 13084472
• MDR Text Key: 282805183
• Report Number: 8010762-2021-00670
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2023
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 3000163740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1