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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

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SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-04
Device Problems No Device Output (1435); Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2016
Event Type  malfunction  
Manufacturer Narrative
Sorin group (b)(4) manufactures the sorin s5 double pump system. 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 sorin centrifugal pump 5 (cp5) display went black and the rpm and flow fell to zero during a procedure. The tech support at the facility reported that there was no patient death or serious injury, however the current patient status could not be provided. The customer reported that this issue has occurred before, and the ep pack is suspected to be the cause. A sorin group field service representative was dispatched to the facility to investigate. Serial readouts were performed for several modules, the double roller pump and the cp5. The ep pack was removed from the cp5 and a loan unit was fitted. The unit was functionally tested and no issues were found. A review of the dhr could not identify any deviations or nonconformities relevant to the issue. The replaced ep pack has been requested for return to sorin group (b)(4) for further investigation. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the sorin centrifugal pump 5 (cp5) display went black and the rpm and flow fell to zero during a procedure. The tech support at the facility reported that there was no patient death or serious injury, however the current patient status could not be provided.
 
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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 Key5956893
MDR Text Key54944734
Report Number9611109-2016-00606
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
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 08/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-01-04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2014
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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