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

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.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, 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 Key: 5852016
• MDR Text Key: 51338829
• Report Number: 9611109-2016-00499
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 58 YR
• Patient Weight: 75