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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 60-02-60
Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Electro-Static Discharge (2149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
The device manufacturer date provided in the initial report was incorrect. The correct device manufacturer date is october 6, 2015. Livanova (b)(4) manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The cp5 was returned to livanova (b)(4) for further investigation. During evaluation, the reported issue could not be reproduced. The device was functionally tested, tested in a climate chamber, and underwent "electric static discharge" testing. No deviations or abnormalities were identified. For safety reasons the cp5 is planned to be scrapped. As the issue could not be reproduced, a root cause was not determined.
 
Manufacturer Narrative
(b)(4) manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). This medwatch report is being filed on behalf of (b)(4). The device was sent to the (b)(4) service center for testing. The unit was tested over a one week period and the reported issue could not be reproduced. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
(b)(4) received a report that the centrifugal pump 5 (cp5) powered off during a procedure after receiving a small static shock when it was touched by the operator. The power switch of the device was immediately turned off and back on but unit did not restart. The operator tried again several seconds later and the device began working again. There was no report of patient impact.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6535764
MDR Text Key250164279
Report Number9611109-2017-00320
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-60
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2015
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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