MAUDE Adverse Event Report: JULIA KAPFENBERGER QUADROX-ID PEDIATRIC; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD 30000-USA

Device Problem Increase in Pressure (1491)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

The reported event occurred in usa.The customer reported a high delta p and the occurrence of clotting on multiple occasions when using the quadrox-id pediatric together with a non ¿ maquet spectrum medical pump.  complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in usa.The following complaint information was provided to maquet cardiopulmonary:¿ caitlin blau, ccp perfusion manager at mayo rochester location called me to discuss occurrences that they are noticing with their new spectrum carts on pediatric patients.These patients are on a spectrum quantum pump with pediatric quadrox id oxy.A picture was provided.She stated that they are observing: 1.Clotting issues and what appears to be a shorter run time before they need to change out the oxygenator.2.A strange clot pattern on the oxygenator.3.Pump makes strange noises at times.We have now experienced this on multiple occasions when utilized with the spectrum medical pump.All circuits had an extremely high delta p (>100 mmhg) prior to changing out.I am in the process of gathering data to learn more.The customer shared that they feel this is a spectrum issue (non getinge product) and that she was not planning to report this as a complaint to us.Additional event information was requested at the customer and no reply / additional information was received despite several attempts.A product for technical laboratory investigation was not returned by the customer.A lot or serial number of the product(s) was not provided, thus a device history record review was not possible.Thus a confirmation of the reported failure "extremely high delta p" & "clot pattern on the oxygenator" was not possible.The exact root cause of the reported event remains unknown.According to the risk file following root cause can lead to the reported failure: no anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.Weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation.Use anticoagulants; e.G.Heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).Ensure that the act value does not fall below the value which is appropriate for the application.Check the coagulation status of the patient's blood regularly.The protocol for coagulation management is the responsibility of the user in charge.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.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-ID PEDIATRIC
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16384583
• MDR Text Key: 309639290
• Report Number: 8010762-2023-00086
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD 30000-USA
• Device Catalogue Number: 701070397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1