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

Model Number HLS SET

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the hls module was disconnected from the cardio help during patient treatment.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the hls module was disconnected from the cardiohelp during patient treatment.No harm to any person reported.They changed the set out and tried to replicate the error with the old hls set using a second cardiohelp unit and could not replicate.The affected product was not available for further investigation as it was discarded by the customer without any notes of the lot number.No visible damage was noticed on the hls set or the cardiohelp, neither before nor after the event by the customer.Based on the given information, the cause of the event could not be attributed to the device.Thus the reported failure could not be confirmed.According to the hls risk assessment (dms#1468452, v26) the most probable root cause is that hls module was not securely fixated into the cardiohelp-i-drive.In the instruction for use ( hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v1.5, chapter 5.3.1 safety instructions for the oxygenator) is stated to 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.In order to avoid the reoccurrence of the reported event the ssu (sales and service unit) should inform the user about the investigation results and the above mentioned sections of the ifu.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: 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: 12376469
• MDR Text Key: 268425673
• Report Number: 8010762-2021-00476
• 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,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1