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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-80-00
Device Problem Decreased Pump Speed (1500)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue. The encoder and the processor board were replaced as precaution. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A video was shared with livanova. The results of the analysis will be provided in a supplemental report.
 
Event Description
Livanova received report that the rpms on a s5 roller pump dropped to zero twice during setup. There was no patient involvement.
 
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Brand NameS5 ROLLER PUMP
Type of DeviceCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 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 Key12281289
MDR Text Key265182096
Report Number9611109-2021-00417
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071318
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
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-80-00
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 Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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