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

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Failure to Deliver (2338)

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

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

From the usa it was reported that initially there were no issues and the rpm's were 3250 with a flow 4.9 lpm's and pven of neg 88.However, after a few minutes the pven quickly increased to neg 300 and flow stopped while the rpm's remained at 3250.The customer inspected the tubing and pump head for clot and none was visible.Because the patient was dependent on support cpr was administered while a new hls set and pump were prepared.Support was then continued with no negative consequences to the patient.The affected oxygenator was investigated in the (b)(4) laboratory on 2021-09-28.It was found that the pump module was disconnected from the oxygenator as well as the blood inlet line on the pump module was broken off by the customer.In order to be able to perform full functional tests in order to identify the root cause of the reported failure, it is mandatory that the product is not disassembled before sending to the manufacturer.Therefore, no functional tests could be performed on this oxygenator.The failure mode "no flow and high negative pven" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)): limited preload, too low collection of venous return.In consultation with the (b)(4) medical affairs team the high negative pressure on the venous side indicates a lack of volume.This was followed by a pressure-triggered pump stop.This can be caused by bleeding of the patient or volume shifting to the tissue.The production records of the affected hls module were reviewed on 2021-09-29.According to the final test results, the oxygenator with the serial# (b)(4) passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on these investigation results no product related malfunction could 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 cardiopulmonarys trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

It was reported that initially there were no issues and the rpm's were 3250 with a flow 4.9 lpm's and pven of neg 88.However, after a few minutes the pven quickly increased to neg 300 and flow stopped while the rpm's remained at 3250.The customer inspected the tubing and pump head for clot and none was visible.Because the patient was dependent on support cpr was administered while a new hls set and pump were prepared.Support was then continued.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: 12554086
• MDR Text Key: 274071471
• Report Number: 3008355164-2021-00026
• 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: Distributor
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000160183
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Distributor Facility Aware Date: 09/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention