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

Model Number BEQ-HLS-7050

Device Problem Inaccurate Delivery (2339)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

The product in question was discarded by the customer, therefore a laboratory investigation of the manufacturer was not possible.To perform a device history record review was also not possible as the customer was not able to provide the lot and serial numbers after the product was discarded.After a follow up conversation of the sales and service unit usa with the customer it was confirmed that the patients pco2 (carbon dioxide partial pressure) level was within normal range.Based on the fact that the customer increased the sweep gas in order to maintain adequate pco2 levels the most probable cause of the reported event could be an insufficient gas to blood flow ratio during the event.The ifu of the product hls set advanced 1.6 | g-670 | 03 does state the following: 6.4 starting perfusion: ensure an adequate gas flow and gas-to-blood flow ratio.With veno-arterial extracorporeal circulation (v-a ecls), start perfusion with a gas-toblood flow ratio of 1:2 and an oxygen content of at least 80%.With veno-venous extracorporeal circulation (v-v ecls), start perfusion with a gas-toblood flow ratio of 1:2 and an oxygen content of at least 100%.Ensure an adequate gas mix and gas flow.At the beginning of the perfusion, getinge recommends setting the gas-to-blood flow ratio to 1:2 and an oxygen content of at least 80%.Check the gas flow settings shortly after beginning extracorporeal circulation.Adjust the oxygen content and the blood flow to gas flow ratio according to the measured values.6.5 performing perfusion: possible measures based on completed blood gas analysis: pco2 high -> increase gas flow.Thus the reported failure could be confirmed but was most probable not attributed to a device related malfunction as written above.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.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

The following complaint information was provided to maquet cardiopulmonary: "the hls oxygenator is being questioned if it is working properly.The pco2 coming out of the oxygenator is a lot higher than the patients pco2.The hls set has been left on the patient.Post oxygenator-65mmhg patient-42mmhg".Furthermore the customer threw away the disposable.The customer used the questionable oxygenator the entire case.The customer said they just used a higher sweep gas.The patients pco2 (carbon dioxide partial pressure) on the patient was within a normal range.No further information could be obtained from the customer.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): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11554847
• MDR Text Key: 259977899
• Report Number: 8010762-2021-00206
• 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
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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 Catalogue Number: 70105.2794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1