Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HLS-7050
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
It was reported that when plugging in the pressure cable there was no venous pressure reading (pven).It was just a dash on the screen.The pressure cable was exchange but the failure did continue.It occured during priming prior to patient treatment.The product then had to be used on the patient as the customer don't carry a spare hls set on retrieval.The circuit was exchanged when the customer got back to the base.Complaint id: (b)(4).
 
Manufacturer Narrative
It was reported that when plugging in the pressure cable there was no venous pressure reading (pven).It was just a dash on the screen.The pressure cable was exchange but the failure did continue.It occured during priming prior to patient treatment.The product then had to be used on the patient as the customer don't carry a spare hls set on retrieval.The circuit was exchanged when the customer got back to the base.No harm was reported.The affected product was not available for technical investigation of the manufacturer.Thus it was not possible to determine the exact root cause of the reported event.However this failure could be linked to our risk management file hls set advanced (dms#(b)(4) and the following most probable cause could be associated with the reported failure: wrong pressure measurement due to malfunction of the pressure sensor.The production records of the affected hls modules (batch # 3000180543 ) were reviewed.Following tests are performed according to the bop as a 100 % inspection: gluing of sensors.Gluing of cover for temperature and pressure sensor.Functionality test hls module (sensors and pump).According to the final test results, all oxygenators passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the above mentioned investigation results the reported failure "no venous pressure reading" could be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12834154
MDR Text Key280927912
Report Number8010762-2021-00611
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K102726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/02/2022
Device Model NumberBE-HLS-7050
Device Catalogue Number701069073
Device Lot Number3000180543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2021
Is the Device Single Use? No
Type of Device Usage A
Patient Sequence Number1
Patient SexPrefer Not To Disclose
-
-