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

Model Number HLS SET ADVANCED

Device Problems Decrease in Pressure (1490); Deformation Due to Compressive Stress (2889)

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

Event Date 05/21/2023

Event Type  malfunction  

Event Description

It was reported that the perfusion staff put two pigtail sample ports on the post oxygenator side.The failure occurred during treatment.One on the top leur and one on the bottom outlet leur.The blood gas samples from the 2 ports are showing around a 200 point difference in po2 (260 top versus 450 bottom).The customer believes that he created that issue described caused by following event:there was line kink during treatment which caused high negative pressure and an air bubble/deprimed portion at the top of the oxygenator.This bubble was debubbled/reprimed from the top port.The customer is unsure if this incident damaged the top fibers.The hls set was not exchanged.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the perfusion staff put two pigtail sample ports on the post oxygenator side.One on the top leur and one on the bottom outlet leur.The blood gas samples from the 2 ports are showing around a 200 point difference in po2 (260 top versus 450 bottom).The customer believes that he created that issue described caused by following event:there was line kink during treatment which caused high negative pressure and an air bubble/deprimed portion at the top of the oxygenator.This bubble was debubbled/reprimed from the top port.The customer is unsure if this incident damaged the top fibers.The hls set was not exchanged.The complaint details were investigated by getinge life cycle engineers on 2023-07-13 with following conclusion: in the instruction for use of the affected hls set, in chapter 6.5 "performing perfusion - blood gas analysis", it is pointed out that incorrect blood values can result from a wrong blood collection site.In this case the collection at the "quick vent" connector caused the wrong blood values.Therefore the most probable root cause is determined as an user error.The product will not be investigated further technically.The production records of the affected #shls module were reviewed on 2023-07-31.According to the final test results, the hls module passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "wrong blood values" could be confirmed, but is not device related.This complaint was found in the database of customer complaints for the hls set as a single event (timeframe from 2022-05-24 till 2023-05-24).The customer will be informed about the results by the getinge sales and service unit.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.H3 other text : there was no device problem.

Event Description

Complaint id# (b)(4).

• Brand Name: TUBING SET
• 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: 17030790
• MDR Text Key: 316282755
• Report Number: 8010762-2023-00255
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: HLS SET ADVANCED
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 3000269163
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1