• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-00-60
Device Problem Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2015
Event Type  malfunction  
Manufacturer Narrative
Sorin group (b)(4) manufactures the centrifugal pump system cp5. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the customer experienced a problem with the centrifugal pump system cp5 after a firmware upgrade due to changes from the previous software version. There was no report of patient injury. The device was not returned, however sorin group (b)(4) r&d evaluated the software and could confirm the described error. Troubleshooting found the issue to be related to a software bug in the firmware. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. As a correction, change order (b)(4) was made and a new firmware version has been implemented (fen 2015-036). Software was evaluated by sorin r&d.
 
Event Description
Sorin group (b)(4) received a report that the customer experienced a problem with its centrifugal pump system cp5 after a firmware upgrade due to changes from the previous software version. There was no report of patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSORIN CENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5626341
MDR Text Key44350824
Report Number9611109-2016-00287
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 10/01/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-00-60
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 Received10/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-