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 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that the hls set was used to initiate ecls support on a patient.The black pressure/sensor cable was attached and the device would not provide a part arterial pressure reading.They decided to use another hls kit and there was no issue with the second hls.The patient was fully supported at all times and there were no adverse outcomes.Complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in usa.The following complaint information was provided to maquet cardiopulmonary:"the hls set was used to initiate ecls support on a patient.The black pressure /sensor cable was attached and the device would not provide a part pressure reading.They decided to use another hls kit and there was no issue with the second hls.The patient was fully supported at all times and there were no adverse outcomes." no harm was reported.The affected product was technically investigated at the laboratory of the manufacturer.During a functionality check of the sensors no arterial pressure value was monitored.Furthermore no delta p value was calculated as the arterial pressure value was missing for calculation.All other pressure and temperature values were measured.The pump housing was opened and the sensors, cables and connectors were checked.No damages or abnormalities were detected.Thus the reported event "no part pressure reading" could be confirmed.It was not possible to determine the exact root cause of the reported event.Most probable an electronic malfunction of the arterial pressure sensor did led to the reported event.Additional laboratory investigation actions are currently ongoing.A follow up report will be submitted when the investigation was completed.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).

Manufacturer Narrative

The affected product was technically investigated at the laboratory of the manufacturer.During a functionality check of the sensors no arterial pressure value was monitored.Furthermore no delta p value was calculated as the arterial pressure value was missing for calculation.All other pressure and temperature values were measured.The pump housing was opened and the sensors, cables and connectors were checked.No damages or abnormalities were detected.Furthermore the pressure sensor itself was investigated.No visible damages were detected at the chip, the sensorpins as well as the bonding between the chip and the sensorpins.Thus the reported event "no part pressure reading" could be confirmed.It was not possible to determine the exact root cause of the reported event.Most probable an electronic malfunction of the arterial pressure sensor chip did led to the reported event.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: 15037710
• MDR Text Key: 301946678
• Report Number: 8010762-2022-00275
• 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,Followup
• Report Date: 07/18/2022

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
• Device Catalogue Number: 701069078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 08/30/2022; 10/04/2022
• Supplement Dates FDA Received: 09/20/2022; 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1