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

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

Device Problems Disconnection (1171); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2022

Event Type  Injury  

Event Description

The event occurred in usa during patient treatment.The customer stated that the beq-hmod70000-usa #squadrox-id ad.O.Fil.Was in use and the ecmo circuit disruption leading to blood loss requiring treatment.Complaint-id: (b)(4).Note: event reported by customer under medwatch 5107559.

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

Complaint id: (b)(4).

Manufacturer Narrative

The customer stated that the beq-hmod70000-usa #squadrox-id ad.O.Fil.Was in use and the ecmo circuit disruption leading to blood loss requiring treatment.The customer disposed the oxygenator and tubing, thus no technical investigation at the laboratory could be performed.The tubing was manufactured and distributed by liva nova.For further investigation the provided information was analyzed by getinge medical experts on 2022-06-22 with following results: ¿most probable the applied cable tie tension by the cable tie gun at the connection between the tubing and oxygenator outlet was not sufficient.This could cause a disconnection at lower pressures than expected.Another aspect could be an incompatibility of the quadrox-id in combination with the livanova tubing which may be observed in the following manners: -an unexpected, yet slightly, larger inner diameter of the tubing may lead to greater possibility of tubing disconnection from the barbed connector due to decrease in surface area contact.-a greater resistance, or decrease in pliability, of the tube itself due to a change in tubing shore.A change in tubing shore may account for a need to apply increased tension to particular tie band to assure proper fixation of the connector and the tubing junction.-the maquet bioline instruction for use state the following with respect to the use of differing coatings: ¿interactions between bioline coatings and coatings from other manufacturers are unheard of, but cannot be ruled out.Therefore, devices coated with bioline coating must not be combined with systems featuring other coatings.Combinations of maquet coatings can be used without any problems¿.In accordance with the quadrox-id risk analysis following most probable root causes were determined as: -lack of attention on device handling; -inappropriate fixation.The production records of the affected quadrox-id were reviewed on 2022-06-15.According to the final test results, all oxygenator with lot# 3000189177 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.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 adult | g-605 | version 04 | us chapter: 4.2 safety instructions for the extracorporeal circulation: the detachment of unsecured tube connections can lead to blood loss and air embolisms in the patient.¿ check that tube connections are correctly and securely fastened.¿ secure all tube connections in the tube system with hose ties.Mechanical forces may act on the components during the application.This can lead to blood loss, embolisms and inadequate patient support.¿ secure all connections.¿ avoid excessive tension and check the integrity and leak-tightness of the components immediately.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.

• 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: 13838954
• MDR Text Key: 287525197
• Report Number: 8010762-2022-00096
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 3000189177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Prefer Not To Disclose