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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Problems Failure to Calibrate (2440); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 03/20/2021
Event Type  Death  
Manufacturer Narrative
The product and further information (patient data, perfusion protocol) was requested but not yet received. A follow-up emdr will be submitted when additional information becomes available. Please note this case is connected to complaint# (b)(4) (second hls set involved) which will be reported under emdr# (b)(4).
 
Event Description
The customer reported that during priming it was not possible to zero the pressures. Further the pump made an unusual noise during priming. While setting up another circuit the patient expired. See detailed description from customer below: "(b)(6) stated that she was requested to prime a cardiohelp circuit and provide for use in the er for a patient. A female patient with a date of birth was (b)(6) 1980. Suspected severe pulmonary embolism. Pamela described that the patient was obese. Patient weight was reported as 143 kg but the patient height was not available. The patient was receiving chest compressions for two hours prior to attempting to place the patient onto cardiohelp therapy. (b)(6) stated she initially attempted to prime the hls circuit with lot number 7014365 on the cardiohelp console with serial number (b)(4). She stated that the circuit was dry but she was not able to zero the pressures. She abandoned attempting to zero the pressures and released the priming solution to prime the circuit via gravity. Once the prime by gravity was completed she set the rpms of the system to 3000 rpms and immediately started to hear a noise. She set the rpms to zero and then set the rpms to 3000 and heard the noise again. Due to this noise she set the rpms to zero, powered down the system and isolated it. Later she was able to replicate the noise and captured a video with sound of the noise. This video is attached to this complaint. When i arrived on monday (b)(6) 2021 the pump and circuit were isolated and still attached. The circuit was still primed with solution and (b)(6) and (b)(6) were able to show me that it was no longer making noise and was achieving flow. The circuit and pump are currently isolated in the perfusion office. I advised that i would be report this complaint and request a biohazard kit to be sent to the facility for the return of lot 70143635. I advised them that their biomed team could contact getinge service to request a pump inspection via their premier service plan for this pump via contract number (b)(4). Please note that this circuit and this pump was not used on the patient. " please note this case is connected to complaint# (b)(4) (second hls set involved) which will be reported under emdr# (b)(4). Complaint id: (b)(4).
 
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Brand NameHLS SET ADVANCED 7.0
Type of DeviceOXYGENATOR, 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 Key11594595
MDR Text Key243101722
Report Number8010762-2021-00226
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 Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number70105.2794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 03/31/2021 Patient Sequence Number: 1
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