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

Model Number BO-HQV 84800#

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when futher information becomes available.

Event Description

It was reported the incident reported by the customer ikem to sukl for material 701052210 bo-hqv 84800#tubing pack.The images provided by the customer show blood leakage at oxygenator blood inlet connector connected to the tube.There is no patient harm.Complaint #: (b)(4).

Manufacturer Narrative

It was reported the incident reported by the customer ikem to sukl for material 701052210 bo-hqv 84800#tubing pack.The images attached to this record show blood leakage at oxygenator blood inlet connector connected to the tube.The failure found during patient use.The immediate action performed by the user is unknown.No harm to any person was reported.The complaint sample was received.During the visual inspection a crack was found in the luer connection.There is no other damage could be detected.Due to the defect of the luer at the blood inlet connector the integrity test according to testing bloodside for tightness did not pass.Therefore, the leakage at the blood inlet is confirmed.The crack in the luer connection may be attributed to the following causes: damage occurred due to improper handling.Material fatigue caused by excessive torque when tightening peripherals linked to the luer.Use of non-specified luer caps.The production history record (dhr) of the affected bo-hqv 84800 with lot # 3000300515 was reviewed on 2023-11-08.According to the dhr results, the product bo-hqv 84800 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The production records of the affected oxygenator (part material number: 701067792 / unique device identifier (udi): (b)(4) / lot number: 3000289125) were reviewed on 2023-11-29.Following tests are performed according to the bop (basic operation procedure) as a 100 % inspection: leak test after welding.Pressure test heat exchanger.Leak test water side.Leak and flow test gas side.Pressure test blood side.Coating test.According to the final test results, the oxygenator with the udi# (b)(4) passed the test as per specifications.Production related influences can be excluded.In addition to the results of the conducted investigations, it must be mentioned that various tubing connections were not secured with cable ties.This is required in the ifu (instructions for use: hlm tubing sets g-006; quadrox-i adult/small adult g-300) with corresponding warning instructions.The unintended detachment of unsecured tubing connections can lead to blood loss and air embolism.The technical drawing was reviewed of the affected product.It could be seen the oxygenator blood inlet connector was closed with a cap.There is no tube connection on that part.The leaked connection was made during assembly of the product for operation.It could be seen in the provided photograph the connection was not secured with cable tie.The mitigation for this possible risk is covered in the ifu: connection securement is part of ifu quadrox-i small adult / adult, g-300 v07, page 11: "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." 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: "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.Avoid intra-hospital transportation." the occurrence rate was calculated for the reported failure and product 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 #:(b)(4).

• Brand Name: TUBING SET
• 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: 17849690
• MDR Text Key: 324658084
• Report Number: 8010762-2023-00484
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BO-HQV 84800#
• Device Catalogue Number: 701052210
• Device Lot Number: 3000300515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.