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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS SET
Device Problem Fluid/Blood Leak (1250)
Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)
Event Date 11/01/2023
Event Type  Injury  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported that there was initially a small number of water drops in the tray underneath the oxygenator.The leak was observed.Later on the clinical decision was made to exchange the hls set.On treatment day three the patient had an acute cardiac event.Complaint id (b)(4).
 
Manufacturer Narrative
It was reported that there was initially a small number of water drops in the tray underneath the oxygenator.The leak was observed.Later on the clinical decision was made to exchange the hls set.On treatment day three the patient hat an acute cardiac event.The affected hls set was investigated by the getinge laboratory on 2024-01-17 with following conclusion: the failure could not be confirmed, as the product functioned as expected.The most probable root cause for the inspection of the customer could be condensated water which was on the gas outlet and seemed like a leakage.The building of the water is due to the environmental temperature/humid, temperature of the water side and temperature of the blood side.Technically, there is no negative influence of the product performance.A medical review was performed by getinge medical affairs on 2024-02-01 with following conclusion: "as no further information has been divulged by the customer (despite multiple requests), the conclusion of the reported event is based on the information received from the customer in the initial complaint, including video evidence, and the investigation report.In the video evidence, which was submitted by the customer, the ¿different source¿ of leakage was identified as the emergency gas outlet.In addition, as demonstration of the leakage the gas outlet was closed with a finger for a short period.This short-term closure of the gas outlet inevitably leads to a short-term increase in gas pressure in the oxygenator, which caused the release of condensate from the exhaust port.Furthermore, the inspection report of the affected hls set assumes that the observed water leak by the user is condensed water which has accumulated on the inner surface of the gas outlet/ emergency gas outlet and in the area of the outer cover above, as all tests of the set passed.Last, there is no evidence that the condensate accumulation resulted in malperformance of the product." as stated in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 ¿ in chapter 7.2 indications for replacing the set: "replacement of the set can be indicated in the cases of leakage, penetration of air, visible deposits in the set, increase in pressure drop, and/or insufficient oxygenation or carbon dioxide elimination at maximum gas flow or 100% fio2.As far as gas transfer and pressure increase are concerned, the decision to replace the set depends on the particular situation.The indication for replacing the hls set advanced is detailed below by way of example.An increased pressure drop can be tolerated within the limits stated above if the gas transfer and arterial blood gas analysis values are still good.If an increase in pressure drop is coupled with deteriorating gas transfer and there are indications that this development is set to continue, a replacement should be carried out as quickly as possible.Assessment of the situation and the decision whether or not to replace the set is the responsibility of the physician in charge of treatment".Additionally, in the chapter 4.3.1 safety instructions for the oxygenator "due to a temperature gradient between the water and the gas supply as well as the ambient conditions, condensation could form in the hls module advanced during the water leak test which could lead to steam permeation.Perform the water leak test before you start the gas flow with an untempered medical gas/oxygen supply.Make sure that the temperature gradient between the environment and the water circuit is as small as possible.Monitor the hls module advanced for signs of condensation.Do not use the hls module advanced if there are signs of condensation".According to the final test results, the modul passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "gas outlet leakage" could not be confirmed.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.
 
Event Description
Complaint id# (b)(4).
 
Manufacturer Narrative
The affected hls set was investigated by the getinge laboratory on 2024-01-17 with following conclusion: the failure could not be confirmed, as the product functioned as expected.The most probable root cause for the inspection of the customer could be condensated water which was on the gas outlet and seemed like a leakage.The building of the water is due to the environmental temperature/humid, temperature of the water side and temperature of the blood side.Technically, there is no negative influence of the product performance.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
Complaint id: (b)(4).
 
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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 Key18099035
MDR Text Key327697567
Report Number8010762-2023-00551
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/04/2024
Device Model NumberHLS SET
Device Catalogue Number701069065
Device Lot Number3000314522
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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