MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH S5 DOUBLE HEAD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 10-85-00

Device Problem Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 double head pump that was being used for cardioplegia failed to start during a procedure.The pump was started manually using the speed control knob and the delivery was completed.There was no report of patient injury.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 s5 double head pump that was being used for cardioplegia failed to start during a procedure.The pump was started manually using the speed control knob and the delivery was completed.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being field filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative could not confirm or reproduce the reported issue.Additional information, during the incident the pump symbol in the plegia display and lid symbol remained red.As a precautionary measure the field service representative moved the rollerpump to a sucker position (green/red position).All menu settings checked, unit disassembled and carried out internal inspection.No abnormalities found.Extensive running/soak tests and functional testing passed successfully.No problem with hardware or software.As a precautionary measure on the s5 software rev of s5= rev193 will be updated on the next planned preventative maintenance service.A review of the dhr did not identify and deviations or non-conformities relevant to the reported issue.Livanova rep evaluated the device onsite.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich,
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5231843
• MDR Text Key: 31450798
• Report Number: 9611109-2015-00547
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071318
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2013
• 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