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

Model Number BE-HLS-7050

Device Problem Noise, Audible (3273)

Patient Problems Hemolysis (1886); Ischemia (1942)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that during patient treatment massive hemolysis, accompanied by vibration and high frequency noise originating in the device occurred.Stabilization after system and extracorporeal circuit change.No other information was provided at this time.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The following complaint information was provided to maquet cardiopulmonary: "occurrence of massive hemolysis, accompanied by vibration and high frequency noise originating in the device.".Additional event information was requested by mcp but not provided by the customer despite several attempts.The affected product was investigated at the laboratory of the manufacturer.The system was visual inspected, primed according to the ifu and undertaken a functionality check of the pump with water starting with rpm (rotations per minute) of 0 up to 5000 rpm and a flow of 0 l/min up to 10 l/min.During the testing no malfunction of the product in regards to the pump, vibrations or abnormal noises were detected.The reported failure "vibration and high frequency noise" was not reproducible.The production records of the affected hls module and pump (batch 3000162353 & 3000165397 ) were reviewed on 2021-12-01.Following steps are performed according to the bop with a 100 % inspection: -hls module / pump glueing; -mounting of pump module; -functionality check of hls module / pump.-mounting of housing pump; -functionality test pump; -tightness check pump.According to the final test results, the oxygenator with the serial# 1805386 and the centrifugal pump with id # 19798 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.However, the reported event was assessed by medical experts of mcp and the following was concluded: a most probable cause of the reported event could be an incorrect connection (or seating) between the hls set and the cardiohelp drive.Improper positioning of the disposable to the cardiohelp drive may have allowed a partial decoupling between the drive and the disposable which resulted shaking (or wobbling) of the disposable pump rotor.Additionally, according to our risk management the following causes could be associated with the reported failure: - insecurely fixated hls module into the cardiohelp drive could result into vibration or damage.Therefore the following measures should be followed: - use the device only together with the device cardiohelp-i.-install or remove the device only when the pump of the cardiohelp-i is at a standstill.- ensure that the device is fitted onto the drive correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump.Based on the investigation results the reported failure "vibration and high frequency noise" could be confirmed but was most probable not contributed by a product related malfunction.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: HLS SET ADVANCED
• 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: 12369189
• MDR Text Key: 268195267
• Report Number: 8010762-2021-00474
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: BE-HLS-7050
• Device Catalogue Number: 701069073
• Device Lot Number: 3000165548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1