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 11/25/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation of the manufacturer is ongoing.
 
Event Description
It was reported that the set was used on the patient the fifth day.The user tried to connect the pigtails on the oxygenator to crrt machine (pigtails were connected at the beginning during priming).Suddenly, the machine alarmed with arterial pressure and delta p alarm, at that time the user hadn't turned on the 3-way on the pigtail yet.Arterial pressure became -500 suddenly.The user checked the circuit and suspected that there was crack around the arterial pressure sensor.The user changed to another new set finally, and no more abnormal alarm on arterial pressure by using the same machine.Complaint id:(b)(4).
 
Manufacturer Narrative
It was reported that the set was used on the patient the fifth day.The user tried to connect the pigtails on the oxygenator to crrt machine (pigtails were connected at the beginning during priming).Suddenly, the machine alarmed with arterial pressure and delta p alarm, at that time the user hadn't turned on the 3-way on the pigtail yet.Arterial pressure became -500 suddenly.The user checked the circuit and suspected that there was crack around the arterial pressure sensor.The user changed to another new set finally, and no more abnormal alarm on arterial pressure by using the same machine.No harm to the patient was reported.The affected product was technically investigated at the laboratory of the manufacturer.A crack (which the customer reported) at the housing of the arterial pressure sensor was confirmed.Thereupon a tightness check was performed, hereby no leakages were confirmed which could have been caused by the observed crack.During a functionality check of the product no abnormal noises were detected.The measurement values of the sensors were plausible, no abnormalities were detected.Thus the reported failure "arterial pressure became -500mmhg suddenly" was not confirmed during product investigation.It was not possible to determine the exact root cause of the reported event during investigation.The observed crack was ruled out as cause for the reported measurement deviation during investigation.It was most probable caused by material stress.However, by the provided picture it was determined that the used sample line (pig tail) was contaminated with blood already when the measurement deviation occurred.In case the 3-way stopcock will be opened it could be possible that this caused a short term pressure drop at the arterial pressure sensor as the connection point of the sample line is located exactly opposite to the measurement head of the arterial sensor.This effect would have been reinforced, in case a relative negative pressure exists at the sample line.Thus, most probable the reported event was caused by a not fully closed 3-way stopcock of the sample line.Maquet cardiopulmonary will inform the user via the ssu (sales and service unit) about the investigation results.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.
 
Event Description
Complaint id: (b)(4).
 
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 Key12907343
MDR Text Key281501538
Report Number8010762-2021-00629
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeHK
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,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/20/2022
Device Model NumberBE-HLS 7050
Device Catalogue Number701069073
Device Lot Number3000187935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
-
-