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

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

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

The reported event occurred in the us.It was reported that the connection between the hls module and the venous tubing were loose.The customer was able to push the tubing further onto the hls module.The cable ties on the same line were unsecured.It was noticed during patient treatment.The affected hls set was not exchanged during patient treatment and is still on patient.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the connection between the hls module and the venous tubing were loose.The customer was able to push the tubing further onto the hls module.The cable ties on the same line were unsecured.It was noticed during patient treatment.The affected hls set was not exchanged during patient treatment and is still on patient.No harm to any person has been reported.The affected product was requested for further investigation but the product was discarded by the customer.Therefore a technical investigation could not be performed at the getinge laboratory.Thus it was not possible to determine the exact root cause of the reported event.By the provided picture it could not be confirmed that the connection between the hls module and the venous tubing were loose.However, the reported failure "loose connection" can be linked to the following most possible root causes according to our risk management file: blood connection too loose.Leakage of blood.Based on the investigation results the reported failure "loose connection" could not be confirmed.The exact root cause remains unknown.The production records of the affected beq-015703112 #shls module advanced adult with packaging lot#3000240860 were reviewed on 2023-05-03 for the reported failure.According to the final test results, the hls module with packaging lot#3000240860 and udi# (b)(4) passed the tests as per specifications.Production related influences are unlikely.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 hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 in chapter.6.5 performing perfusion: the tube connections of the hls module advanced should be checked for leaks.If a leak occurs at the blood inlet connector or the blood outlet connector, secure the tube connection with a third cable tie.Additional cable ties are included into the hls set.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16608461
• MDR Text Key: 312010010
• Report Number: 8010762-2023-00142
• 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: 05/05/2023

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: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1