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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2022
Event Type  malfunction  
Event Description
It was reported that the customer noticed air in the circuit and was unable to remove the air out of the circuit.They decided to exchange the affected hls set with another hls set.They also exchanged the second hls set due to air in the circuit.With the third hls set they have no problems.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.
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that the customer noticed air in the circuit and was unable to remove the air out of the circuit.They decided to exchange the affected hls set with another hls set.They also exchanged the second hls set due to air in the circuit.With the third hls set they have no problems.No harm to any person has been reported.The affected products were technical investigated in the getinge laboratory on 2022-09-16.During priming and a subsequent flow test of both modules, no more air could be detected.Subsequently, a leak test (gas side) was carried out on both complaint samples, which were both passed as tight.Based on the investigation results the reported failure was not reproducible for both samples.However, the failure mode "air remains in system" can be linked to the following most possible root causes according to our risk management file (dms#(b)(4)): hls is not primed.Clamp is not used.Hls is positioned above patient.Pump is started without content.De-airing membrane closed during priming.The production records of the affected two beq-015703112 #shls module advanced adult with packaging lot#3000208256 were reviewed on 2022-09-22.According to the final test results, the hls modules with lot#3000208256 and udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "air remains in system" could not be confirmed.In order to avoid re-occurrence of the reported failure, the sales and service unit (ssu) will inform the customer to follow the chapter in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 g-660 v04 us: follow the chapter 6.2 priming the system during the priming process.6.4 starting perfusion: ensure that the tube system has been completely de-aired before starting the perfusion.Ensure that all connections and luer lock openings are secured or closed before you start extracorporeal circulation.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.
 
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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 Key15274351
MDR Text Key303144830
Report Number8010762-2022-00337
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 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
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
Device Lot Number3000208256
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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