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

Model Number QUADROX-ID SMALL ADULT/ADULT

Device Problem Obstruction of Flow (2423)

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

Event Date 02/02/2023

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

The event occurred in the us.It was reported that the delta pressure increased fast on the quadrox-id during patient treatment.They exchanged the oxygenator during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the delta pressure increased fast on the quadrox-id during patient treatment.The affected quadrox-id was exchanged during patient treatment.No harm to any person has been reported.The affected product was technically investigated at the getinge laboratory on 2023-04-20.During visual inspection of the device no abnormalities could be detected.During the cleaning procedure of the oxygenator no clots have been flushed out.Further the pressure and functional tests shows no abnormalities, the oxygenator works as intended.The reported failure was not reproducible during the technical investigation.Based on the investigation results the reported failure could not be confirmed, no product related malfunction could be determined.The production records of the affected beq-hmod70000-usa #squadrox-id ad.O.Fil.With packaging lot# 3000199597 were reviewed on 2023-04-21 for the reported failure.According to the final test results, all beq-hmod70000-usa #squadrox-id ad.O.Fil.With lot# 3000199597 passed the test as per specifications.Production related influences are unlikely.In order to avoid re-occurrence of the reported failure, the sales and service unit (ssu) will inform the customer to follow the chapter in the instruction for use instructions for use oxygenator quadrox-id adult g-605 version 04 us: 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.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: 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: 16360961
• MDR Text Key: 309367048
• Report Number: 8010762-2023-00081
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: QUADROX-ID SMALL ADULT/ADULT
• Device Catalogue Number: 701067859
• Device Lot Number: 3000199597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1