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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 BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2023
Event Type  malfunction  
Event Description
The reported event occurred in the us.It was reported that the connection between the hls module and the venous tubing were loose.The customer was able to push the tubing further onto the hls module.The cable ties on the same line were unsecured.It was noticed during patient treatment.The affected hls set was not exchanged during patient treatment and is still on patient.No harm to any person has been reported.Complaint id: (b)(4).
 
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.
 
Manufacturer Narrative
It was reported that the connection between the hls module and the venous tubing were loose.The customer was able to push the tubing further onto the hls module.The cable ties on the same line were unsecured.It was noticed during patient treatment.The affected hls set was not exchanged during patient treatment and is still on patient.No harm to any person has been reported.The affected product was requested for further investigation but the product was discarded by the customer.Therefore a technical investigation could not be performed at the getinge laboratory.Thus it was not possible to determine the exact root cause of the reported event.By the provided picture it could not be confirmed that the connection between the hls module and the venous tubing were loose.However, the reported failure "loose connection" can be linked to the following most possible root causes according to our risk management file: blood connection too loose.Leakage of blood.Based on the investigation results the reported failure "loose connection" could not be confirmed.The exact root cause remains unknown.The production records of the affected beq-015703112 #shls module advanced adult with packaging lot#3000240860 were reviewed on 2023-05-03 for the reported failure.According to the final test results, the hls module with packaging lot#3000240860 and udi# (b)(4) passed the tests as per specifications.Production related influences are unlikely.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 in chapter.6.5 performing perfusion: the tube connections of the hls module advanced should be checked for leaks.If a leak occurs at the blood inlet connector or the blood outlet connector, secure the tube connection with a third cable tie.Additional cable ties are included into the hls set.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).
 
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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
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Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key16608461
MDR Text Key312010010
Report Number8010762-2023-00142
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2023
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 Model NumberBEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
Device Catalogue Number701069078
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received03/24/2023
Supplement Dates Manufacturer Received05/02/2023
Supplement Dates FDA Received05/08/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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