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 Device Sensing Problem (2917)

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

Event Date 04/09/2022

Event Type  malfunction  

Event Description

It was reported that the venous pressure changed from around -50 to plus 328 with no change in arterial pressures or flow.The customer replaced the sensor cable on the hls set without fixing the problem, so he returned to the original cable and continued the treatment.Venous saturation as well as blood gas results are unchanged.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information and return of the product 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 venous pressure changed from around -50 to plus 328 with no change in arterial pressures or flow.The customer replaced the sensor cable on the hls set without fixing the problem, so he returned to the original cable and continued the treatment.Venous saturation as well as blood gas results are unchanged.No harm to any person has been reported.The affected product was not available for technical investigation of the manufacturer as it was disposed off by the hospital.Thus the exact root cause of the reported failure "venous pressure increased" could not be determined.The production records of the affected hls module (batch #3000188548) were reviewed on 2022-05-04.Following tests are performed as a 100 % inspection: gluing sensors; montage flexible conductor; function test; final product test.According to the final test results, the affected hls module with udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the above mentioned results the reported failure "venous pressure increased" could not be confirmed.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: 14139931
• MDR Text Key: 289511414
• Report Number: 8010762-2022-00122
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1