MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S3 ROLLER PUMP MODULE SORIN S3 CONSOLE ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 43-30-00

Device Problem Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 03/07/2015

Event Type  Death  

Event Description

Sorin group received a report that during an emergency procedure on a pediatric pt there was power surge that caused the pump to stop.The pump reportedly did not switch to the emergency power source and therefore they hand cranked it to maintain flow.The pt expired but it is unk if this was a result of the pump stop or the condition of the pt.The pt was a premature baby with underdeveloped lungs.

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) mfr the s3 roller pump module s3 console.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that during an emergency procedure on a pediatric pt there was a power surge that caused the pump to stop.The pump reportedly did not switch to the emergency power source and therefore they hand cranked it to maintain flow.The pt expired but it is unk if this was a result of the pump stop or the condition of the pt.The pt was a premature baby with underdeveloped lungs.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that during an ecmo procedure there were several power surges and/or fluctuations.The first two caused the pump to slow down and the third caused the pump to stop.The pump reportedly did not switch to the emergency power source and therefore they hand cranked it to maintain flow.The patient expired but the hospital was unsure it was related to the pump stop.Sorin requested that the power supply (mains module), ups charging module, ups control and dc/dc modules be returned for evaluation.These were sent to sorin group (b)(4) for further investigation.The results of their investigations are found below.S3 mains module: the module was integrated in a test qa-e/p-pack, then a ups-case was simulated and the e/p-pack switched to battery power as intended.During the visual inspection the module was opened and both pcb's checked, as well as all internal connections, but no problem could be identified.During the test run the device was switched off/on several times using the main switch and it worked according to specification.S3 ups control module: the batteries charged correctly, the switch to battery mode was working and a discharging test was completed successfully.During the visual inspection the module was opened and all internal connections checked, but no problem could be identified.During the test run the device was switched off/on several times using the main switch; no deviations could be found.It worked according to specification.S3 ups charging module: the batteries were charged, the switch to battery power worked, as well as starting without the mains and emergency start.The module was opened, both pcb's visually inspected, but no problem could be found.A discharge test could be successfully completed.During the test run the device was switched off/on several times using the main switch, but no problems could be found.It worked according to specification.S3 dc/dc module: the voltages were checked and +5v/+12v/-12v were available.The module was opened, the pcb visually inspected but no problem could be found.The module was reconnected, all voltages measured again and no deviation could be identified.During the test run the device worked without any problems and no faults could be identified.Evaluation of all the returned modules could neither confirm nor reproduce the described problem.A review of the device history records could not identify any deviations or nonconformities relevant to the reported failure.All testing confirmed that the product performed according to specification.

Manufacturer Narrative

"date of this report" on initial report was 03/09/2015, but it should have been 03/07/2015."date received by manufacturer" on initial report was 03/09/2015, but it should have been 03/07/2015.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s3 roller pump module s3 console.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that during an ecmo procedure there were several power surges and/or fluctuations.The first two caused the pump to slow down and the third caused the pump to stop.The pump reportedly did not switch to the emergency power source and therefore they hand cranked it to maintain flow.The patient expired but the hospital was unsure it was related to the pump stop.A service representative performed an onsite evaluation of the unit and was unable to reproduce the reported failure.The unit was power cycled from ac to battery several times with no errors.The clinician stated that the units had not been used for approximately 11 months so as a precaution the batteries were replaced.The boards in the pump were checked and showed no issues.A preventative maintenance and battery test was performed.Testing was completed without any problems.The replaced batteries were sent to sorin group (b)(4) for further evaluation.The facility did not return the unit directly to service.They decided to run the unit for 2 weeks to determine if the problem could be reproduced again.The reported issue could not be reproduced.The unit ran without any issues.It was then returned to service.A follow-up call by the service representative found that the battery discharge tests being performed at the facility had no issues indicating that the battery system was working correctly.Sorin group (b)(4) evaluated the returned batteries and the reported failure could not be reproduced.Visual check, functional testing and analysis could not identify any issues with the batteries.The capacity was within tolerance (>17amp hours).A review of the device history record did not identify any deviations or nonconformities relevant to the reported failure.To date, all testing performed by the sorin service representative, the facility and sorin group (b)(4) has not been able to reproduce the reported problem and has shown no evidence of a device malfunction.The pump is still in use at the facility.As a further precaution, sorin requested that the power supply, ups charge, ups control and dc/dc be returned for evaluation.These have been sent to sorin group (b)(4)for further investigation.A follow-up report will be submitted when this evaluation is complete.

• Brand Name: SORIN S3 ROLLER PUMP MODULE SORIN S3 CONSOLE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindbergh strasse 25; munchen D 809 39; GM D 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 Key: 4664994
• MDR Text Key: 5608346
• Report Number: 9611109-2015-00082
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 43-30-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/30/2016; 10/27/2015; 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2002
• 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