Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The event occurred in japan.It was reported that air bubbles were noticed in the right atrium during patient treatment.The hls set was exchange during treatment.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that air bubbles were noticed in the right atrium during patient treatment.The hls set was exchanged during patient treatment.No harm to any person has been reported.The affected product was technically investigated at the getinge laboratory on 2022-10-04.Since not the whole hls set was sent back by the customer, only the hls module could be inspected.During visual inspection, no damage or abnormalities at the hls module could be detected.As the system had already been pre-cleaned by the customer, no clots could be detected.As the pressure on the gas side dropped during the pressure test, it can be assumed that there was a leak on the gas side, which could have had a positive influence on this complaint.During investigation the hls system could be completely de-aired and any trapped air could be removed.Further laboratory investigation actions are currently ongoing.A follow up report will be submitted when the investigation is completed.The production records of the affected be-015703112 #shls module advanced adult with lot#3000188589 were reviewed on 2022-10-07 for the reported failure.According to the final test results, the hls module with lot#3000188589 and udi# (b)(4) passed the tests as per specifications.Production related influences are unlikely.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
It was reported that air bubbles were noticed in the right atrium during patient treatment.The hls set was exchanged during patient treatment.No harm to any person has been reported.The affected product was technically investigated at the getinge laboratory on 2022-10-04.Since not the whole hls set was sent back by the customer, only the hls module could be inspected.During visual inspection, no damage or abnormalities at the hls module could be detected.For further tests the hls module was connected to a priming bag.As the pressure on the gas side dropped during the pressure test, it can be assumed that there was a leak on the gas side.During investigation the hls system could be completely de-aired and any trapped air could be removed.During a further leak test of the hls module a leak was detected at the venting connector of the venting membrane.The leak was located between the elbow connector and the vent connector.However, this leak cannot be linked to the reported failure, as there is a relative overpressure to the environment in the entire area of the venting membrane during use of the product.This rules out the possibility that air could have entered the system via the leak between the elbow connector and the venting nozzle.A leakage at the venting membrane was not reported by the customer.In particular no deviations were detected in the area of the centrifugal pump, where leaks could lead to air entering the system.During the investigation no possible root cause of the reported failure could be determined.However, the reported failure "air entering the hls set during treatment" can be linked to the following most possible root causes according to our risk management file hls set (dms# 1468452, v26): hard object is used to remove gas bubble; air remains in luer lock access port; de-airing valve remains open throughout the perfusion procedure; air inside emergency priming line.Additional air is getting pushed into the module.The production records of the affected be-015703112 #shls module advanced adult with lot#3000188589 were reviewed on 2022-10-07 for the reported failure.According to the final test results, the hls module with lot#3000188589 and udi# (b)(4) passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "air entering the hls set during treatment" could not 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 cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
Complaint id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15190478
MDR Text Key302931848
Report Number8010762-2022-00311
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2023
Device Model NumberBE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Catalogue Number701069073
Device Lot Number3000227590
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient SexPrefer Not To Disclose
-
-