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U.S. Department of Health and Human Services

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

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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
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 united kingdom.It was reported that a suspected ruptured fiber in the oxygenator was noticed.The hls set was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that a suspected ruptured fiber in the oxygenator was noticed.The hls set was exchanged during patient treatment.The affected product was investigated in the getinge laboratory on 2022-09-02.During visual inspection no damage or abnormalities could be detected.During the performance of the leak test blood side, a leakage occurred from the emergency gas outlet of the product.Therefor the reported failure could be confirmed.The exact root cause could not be determined.The most possible root cause could be determined as the following: insufficient pur (polyurethane) potting of the mat package.Fiber detachment in the pur potting.Fiber damage.The production records of the affected be-(b)(4) #shls module advanced adult with lot#3000210013 were reviewed on 2022-09-06.According to the final test results, the hls module with lot#3000210013 and udi#(b)(4).Passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "leakage at the gas outlet connector" could be confirmed.Maquet cardiopulmonary initiated a non-conformance process in regards to the detected findings.All further actions and investigations will be performed within this process.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).
 
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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 Key14953092
MDR Text Key301200386
Report Number8010762-2022-00265
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/11/2023
Device Model NumberBE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Catalogue Number701069073
Device Lot Number3000215230
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/30/2022
Initial Date FDA Received07/08/2022
Supplement Dates Manufacturer Received09/02/2022
Supplement Dates FDA Received09/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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