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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 ADVANCED
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the cardiohelp device stopped working due to a pump disposable error.The emergency drive was used.There was no adverse event and the patient has not been affected.The cardiohelp as well as the hls set were exchanged during treatment.The hls set was discarded by the customer.No harm to any person has been reported.Complaint id#: (b)(4).
 
Manufacturer Narrative
It was reported that the cardiohelp device stopped working due to a pump disposable error.The emergency drive was used.There was no adverse event and the patient has not been affected.The cardiohelp as well as the hls set were exchanged during treatment.The cardiohelp will be investigated in complaint#: (b)(4) (mfg report number 8010762-2023-00264).The hls set was discarded by the customer.The log files of the reported cardiohelp device were reviewed and the error message "pump disposable error" could be confirmed on the date of event.It was confirmed by the customer that the nurse might have removed the hls set while the rpm was running and that they are sure that this is the root cause for the pump disposable error.In the instruction for use (ifu) is stated that it is necessary to decrease the flow to zero before disconnecting and connecting the disposable to the device.Based on the results the reported failure "pump disposable error - stop " could be confirmed, but was not a device related malfunction.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 : hls set was discarded by customer.
 
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Brand Name
TUBING SET
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key17151117
MDR Text Key317817057
Report Number8010762-2023-00296
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTC
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
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHLS SET ADVANCED
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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