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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 60-02-60
Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/12/2016
Event Type  Death  
Manufacturer Narrative
Patient identifier was not provided. Sorin group (b)(4) manufactures the sorin s5 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 flow probe of sorin centrifugal pump 5 (cp5) displayed a negative flow alarm during a procedure that could not be cleared. The pump was hand cranked for 4 to 5 minutes before transferring to a rollerpump to reestablish flow. However, under-occlusion of the roller pump resulted in low flow and gross air entrainment. The facility reported that the patient is currently in serious condition. A sorin group field service representative was dispatched to the facility to investigate. The service representative performed a serial readout of the cp5 control panel and carried out an internal inspection. All connectors were checked and functional checks were performed without issue. No faults or abnormalities were observed. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the flow probe of sorin centrifugal pump 5 (cp5) displayed a negative flow alarm during a procedure that could not be cleared. The pump was hand cranked for 4 to 5 minutes before transferring to a rollerpump to reestablish flow. However, under-occlusion of the roller pump resulted in low flow and gross air entrainment. The facility reported that the patient is currently in serious condition.
 
Manufacturer Narrative
On august 23, 2016, sorin group (b)(4) learned that the patient expired. The date of death was not provided. Type of reportable event: death. (b)(4). Sorin group (b)(4) manufactures the sorin s5 system. The incident occurred in (b)(4). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the flow probe of sorin centrifugal pump 5 (cp5) displayed a negative flow alarm during a procedure that could not be cleared. The pump was hand cranked for 4 to 5 minutes before transferring to a roller pump to reestablish flow. However, under-occlusion of the roller pump resulted in low flow and gross air entrainment. On august 23, 2016, the customer reported that the patient had expired. The date of death was not disclosed. A sorin group field service representative was dispatched to the facility to investigate. The service representative performed a serial readout of the cp5 control panel and carried out an internal inspection. All connectors were checked and functional checks were performed without issue. No faults or abnormalities were observed. Analysis of the serial readout did not identify any electrical or software failures on the date of the event. The cp5 control panel, cp5 drive unit, flow module and erc clamp were returned to sorin group (b)(4) for further investigation. The cp5 drive unit was tested for 72 hours at 1500rpm. A level alert was simulated and the erc clamp engaged as expected. During testing of the cp5 control panel, the negative flow was only reproduced when the line was manually clamped to cause over-pressurization. When the pressure sensor sensed the over-pressurization, the system tried to equalize the pressure, which generated a minor amount of back flow. The negative flow triggered the erc clamp to engage as expected. The cp5 does not control flow; it only displays it. In case of negative flow, a message is communicated to the arterial clamp to close to safeguard the patient. The investigation was unable to identify any functional issue and found all returned devices to function as designed. Sorin group (b)(4) determined the root cause to be the user technique of manually clamping of the line, leading to over-pressurization and negative flow. Follow-up communication with the customer on august 23, 2016 confirmed that the sorin revolution disposable was used with the cp5, as recommended in the instructions for use (ifu). A review of the all dhrs for all returned devices did not identify any deviations or non-conformities relevant to the reported issue. The service history for the cp5 was also reviewed and no deviations relevant to the reported issue were identified. Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
 
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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
sorin group deutschland
munich, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5852016
MDR Text Key51338829
Report Number9611109-2016-00499
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,Followup
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number60-02-60
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/05/2016 Patient Sequence Number: 1
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