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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-00
Device Problems Decreased Pump Speed (1500); Vibration (1674)
Patient Problem Hemolysis (1886)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp. The incident occurred in (b)(6). A field service technician was dispatched to the facility to investigate the device. No deviations or defects could be identified. Investigation is ongoing. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received report of hemolysis observed in laboratory test results and dark colored urine. The patient had been under ecmo support with a centrifugal pump system approximately for 36 hours. The drive unit was noisy and vibrating. Reportedly, above 2000 rpms, the blood flow decreased even if the pump speed was the same. The user replaced the drive unit and used the same disposables kit on the back-up unit. Above 3000 rpms, vibrations occurred also with the second device. However, they were smaller and support continued and is still on. After drive unit replacement, reduction of hemolysis and no macroscopic hemolysis were observed. The patient required blood transfusion and respirator therapy including oxygen concentration in the breathing mixture 100% and peep > 25.
 
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Brand NameCENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11051036
MDR Text Key223181366
Report Number9611109-2020-00699
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number60-01-00
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/21/2020 Patient Sequence Number: 1
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