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

Model Number QUADROX-ID PEDIATRIC

Device Problem Obstruction of Flow (2423)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that several quadrox-id pedi needed to be exchanged during treatment in the last months.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that several quadrox-id pedi needed to be exchanged during treatment due clotting in the last months.Customer confirmed that no patient or perfusion data will be available.In addition the affected oxygenators were not available for return.Previously the customer reported ¿clotting¿ under complaint (b)(4) reported under mfg 8010762-2021-00118, (b)(4) reported under mfg 8010762-2021-00119, (b)(4) reported under mfg 78010762-2021-00120 and (b)(4) reported under mfg 8010762-2021-00152.A technical investigation was not possible, however, two possible root causes were determined by medical affairs based on the available data: oversized (adult) centrifugal pump compared to the pediatric oxygenator pump newer studies have demonstrated that some adult centrifugal pumps show a decreased hydraulic efficiency at lower flows (viz.Flows below 2.0 lpm and 1.0 lpm) which results in higher incidence of in vitro normalized index of hemolysis.Whether a possible increase in hemolysis, due to an oversized centrifugal pump (with respect to pediatric application), affected the pediatric quadrox-id performance is difficult to determine without an complete examination of the actual membrane.-lower than recommended blood flow using a lower than recommended flow through an oxygenator may cause shifting in the flow pattern of a membrane package to favor some areas while excluding or minimizing other areas of a membrane.The exclusion or minimization of some areas within a membrane package may create a condition that favors clotting within those areas of low to no flow.Additionally in accordance to the risk assessment (quadrox-id pediatric) the reported failure could be linked to the following probable root causes: shear forces leading to blood damage, insufficient anticoagulation, hemostasis.The production records of the affected quadrox-id pedi with lot#3000175348, 3000171202, 3000156906, 3000155155, 3000146017, 3000149492, 3000191266 and 3000155993 were reviewed on 2022-08-05.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.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use oxygenator quadrox-id | g-605 | version 04 | us chapter 4.2 safety instructions for the extracorporeal circulation.Absence of adequate anticoagulation results in clotting within the system and consequently occlusion of the extracorporeal circuit and the patient circuit.This can lead to inadequate patient support, thrombus formation, hemolysis, hemostasis, and ischemia.Use anticoagulants; e.G., heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).The act should not fall below 480 s.Based on the investigation results no product related malfunction could be confirmed.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 : 4115.

Event Description

Complaint id: (b)(4).

• Brand Name: OXYGENATOR
• 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: 13522495
• MDR Text Key: 285530379
• Report Number: 8010762-2022-00051
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-ID PEDIATRIC
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1