MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0

Device Problem Mechanical Problem (1384)

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

Event Date 04/13/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that the perfusionist was transferring an hls set from one cardiohelp console to another after transport.Upon attempted installation of hls set onto second console, the positioning latch of blood inlet cover on the hls module broke.Disposable secured to console with zip ties and perfusionist was able to continue therapy without disruption.No patient demographics reported.No harm reported to patient.The set is still in use on patient.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the perfusionist was transferring an hls set from one cardiohelp console to another after transport.Upon attempted installation of hls set onto second console, the positioning latch of blood inlet cover on the hls module broke.Disposable secured to console with zip ties and perfusionist was able to continue therapy without disruption.No patient demographics reported.No harm reported to patient.The set is still in use on patient.As of 2024 (b)(6) it was confirmed that the hls set was discarded and the patient had weaned off support successfully.On 2024 (b)(6) it was said that the customer suspects there may have been too much force applied when positioning on the positioning pins, resulting in breakage of the plastic positioning piece on the hls set.The part may have been broken by user.The failure occurred during transfer of the hls set from one cardiohelp console to another after transport.No harm to any person has been reported.Due to the above mentioned facts that the product was broke by the user and the product was used until the end of the procedure, the potential risk for the patient is remote, no report in the us is required any longer.The affected product is not available for technical investigation as the hls set was discarded by the customer.Nevertheless, as said by the customer, the most likely root cause was the use of an excessive force by the user.Additionally, according to the risk assessment of the hls set, the following root cause can lead to the reported failure: crack in polycarbonate (pc) at housing.As stated in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, in the chapter 4.3.1 - "safety instructions for the oxygenator", "incorrect installation of the hls module advanced can lead to a device malfunction.This can endanger the patient.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 (0 rpm).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".According to the instruction for use (ifu) of the cardiohelp, chapter 5.2.1 "attaching the disposable for the hls retainer", it is indicated that "if the disposable is not pre-connected, connect it in the tube system before attaching it to the cardiohelp-i.Open the safety bar.Ensure that the safety bar release mechanism clicks into place.Position the disposable on the pump drive turned through approx.10° clockwise.Turn the disposable counterclockwise until vertical.Ensure that the three guide pins are in the corresponding holes in the disposable and the locking device clicks into place.Ensure that the disposable is correctly positioned and securely fixed".The production records of the affected product were reviewed on 2024 (b)(6).According to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.The review of the non-conformities has been performed for the reviewed time period.It does not show any non-conformity in regards to the reported product and failure.Based on the results the reported failure "broken positioning latch of the module" could be confirmed but it is not related to a malfunction of the device.The customer will be informed about the results by the getinge sales and service unit.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.H3 other text : discarded by the user.

Event Description

Complaint id# (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• 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: 19115249
• MDR Text Key: 340275681
• Report Number: 8010762-2024-00210
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• 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
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000314931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1