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

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/23/2021

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 cardiohelp during patient transport.Complaint #(b)(4).

Manufacturer Narrative

It was reported that the hls module was disconnected from the cardiohelp during patient transport.The medical personnel discovered that the oxygenator module has been disconnected by the cardiohelp housing and had to be secured back in place.The affected product was not available for further investigation as it was discarded by the customer.According to the customer, the probable cause of the incident was that the lever that allows the lock and unlock of the hls set from the cardiohelp was in some way unintentionally pressed and the hls was released.In conclusion, the customer believes that nothing has malfunctioned.No visible damage was noticed on the hls set or the cardiohelp, neither before nor after the incident.The production records of the affected hls module were reviewed on 2021-07-07.Following step is performed according to the bop with a 100 % inspection: functionality test hls module according to the final test results, all oxygenators passed the tests as per specifications.Based on this information, the cause of the event could not be attributed to the device.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.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
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11789507
• MDR Text Key: 249436910
• Report Number: 8010762-2021-00292
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Device Lot Number: 70138285
• Date Manufacturer Received: 09/02/2021
• Patient Sequence Number: 1