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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-04
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and could confirm the reported issue.He found a hole on the top of the drive unit and thus he replaced the device.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report of a centrifugal pump 5 (cp5) with the top case worn out and broken apart during procedure.There was no report of patient injury.
 
Manufacturer Narrative
The address in mfr site, report source section has been corrected.
 
Event Description
See initial.
 
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Brand Name
CENTRIFUGAL PUMP 5 (CP5)
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8586654
MDR Text Key147622495
Report Number9611109-2019-00323
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
PMA/PMN Number
K112225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number60-01-04
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/08/2019
Initial Date FDA Received05/07/2019
Supplement Dates Manufacturer Received05/08/2019
Supplement Dates FDA Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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