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

Model Number BEQ-HLS-7050

Device Problem Device Sensing Problem (2917)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is still pending.

Event Description

Ecls (extra corporeal life support) veno - venous support case utilizing 7.0 hls kit.The circuit was primed properly per ifu (instruction for use) instructions.Pressure sensors were "zeroed" prior to priming the circuit.1-2 hours after initializing support, the internal pressure began recording a negative value and began recording variable negative values and triggering alarms that could not be silenced.The internal sensor cable was checked and was in proper position the pump flow and rpm (rotations per minute) requirement to achieve flow was appropriate, and the gas exchange was reported per clinician as not compromised.No visible signs of thrombus formation were noted.The clinicians decided to replace the circuit due to inconsistent pressure values and alarms.The circuit is not available as this is a covid-19 patient.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that 1-2 hours after initializing support, the internal pressure sensor began recording a negative value and began recording variable negative values and triggering alarms that could not be silenced.The product was exchanged.The product was not available for a technical investigation at the laboratory of the manufacturer.Thus a review for a similar complaint with a performed laboratory investigation was performed.No similar complaint with a technically confirmed root cause investigation was found.The production records of the affected hls module (dms# 2950488, 2977717) were reviewed on 2021-04-07.Following tests are performed according to the bop as a 100 % inspection: gluing of sensors, gluing of cover for temperature and pressure sensor, functionality test hls module (sensors and pump).According to the final test results, the oxygenator with the serial# (b)(4) passed the test as per specifications.Production related influences can be excluded.Based on the information available at this time and the fact that the product was not available for technical investigation it was not possible to determine an exact root cause of the reported event.Most probable issues with the pressure transducer (calibration, humidity, functionality) could have led to the malfunction of the internal pressure sensor (with reference to ifu (instruction for use) cardiohelp system 1.8 | en | 09, 9.3.3).Thus the reported failure could be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: 11594592
• MDR Text Key: 245803148
• Report Number: 8010762-2021-00222
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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
• Device Lot Number: 70138158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1