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

Model Number BEQ-HLS 7050 USA

Device Problem Device Sensing Problem (2917)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that the customer was getting readings of pint (internal pressure) 220 mmhg, part (arterial pressure) 600 mmhg, with a delta p of -380 mmhg.He tried troubleshooting with changing the integrated pressure sensor out to no available.It seems to potentially be a pressure sensor malfunction.There were no issues normal pressures during priming.He hooked up external transducers and transduced pressures were -112 pven, 270 part, 293 pint respectively.Hls set is still on the patient currently.No harm to the patient was reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the customer was getting readings of pint (internal pressure) 220 mmhg, part (arterial pressure) 600 mmhg, with a delta p of -380 mmhg.He tried troubleshooting with changing the integrated pressure sensor out to no available.It seems to potentially be a pressure sensor malfunction.There were no issues normal pressures during priming.He hooked up external transducers and transduced pressures were -112 pven, 270 part, 293 pint respectively.They did not keep the hls as the patient was covid positive so the disposed of the unit.No harm to the patient was 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 event "readings of pint 220, part 600, with a delta p of -380" could not be determined.The production records of the affected hls module (batch #3000189757) were reviewed.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 oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.The most probable cause of the reported failure was determined to be an electronic malfunction of the arterial pressure sensor.Based on the above mentioned results the reported failure "readings of pint 220, part 600, with a delta p of -380" could be confirmed.The reported failure did not cause or contribute to serious injury or death.Since no systemic issue was determined no corrective action is required at this time.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 : 4115.

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: 13648472
• MDR Text Key: 286425664
• Report Number: 8010762-2022-00068
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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
• Device Catalogue Number: 701069078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1