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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HLS 7050
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2016
Event Type  malfunction  
Manufacturer Narrative
Maquet cardiopulmonary (b)(4) requested the product for manufacturers investigation but product was not available. Therefore no investigation could be performed and no device history record could be reviewed. A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found. Based on this a confirmation of the failure is not possible. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further investigation initiations will be completed at this time.
 
Event Description
Description from the customer report: "customer reported, that he was using the hand crank because the cardiohelp stopped due to alarm "pint outside of measurement range". After reinstate the oxygenator into the cardiohelp the procedure could moved on without any issues. There was no sign for a oxygenator fail, a clot or any other reason for the high pint. Pint value was between 400-500 mmhg. Customer continued using the set. Product not available for investigation. " (b)(4).
 
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Brand NameHLM TUBING SET W/BIOLINE COATING
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key5886736
MDR Text Key53451161
Report Number8010762-2016-00519
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2018
Device Model NumberBE-HLS 7050
Device Catalogue Number701047753
Device Lot Number70112283
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 Received08/02/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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