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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#HLS SET ADVANCED 7.0
Device Problem Failure to Prime (1492)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing. Further information has been requested but has not yet been received. A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
The event occurred in canada. It was reported that the priming of the hls set was unsuccessful. When the plasmalyte-a was dropped, we were unable to prime by gravity or by increasing rpms. Both perfusionists took turns manipulating the circuit to try to get it primed but to no avail. When the rpms were increased, the console would make a loud rumbling sound, much louder and more vibrations than if the membrane were decoupled, which the perfusionists accounted for by detaching and reattaching the pump to the console as well as reducing the rpm to zero. No indication of actual or potential for harm or death has been reported. The set was not used for treatment. Due to the delay in procedure (50 second arrest time) and the device was changed within the reported event a report is required. The event will be investigated in further complaints: (b)(4), (b)(4), (b)(4). Complaint id: (b)(6).
 
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Brand NameHLS SET ADVANCED
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key11759098
MDR Text Key250842395
Report Number8010762-2021-00279
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2022
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Device Lot Number3000147588
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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