MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 10-60-00

Device Problem Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s3 roller 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 s3 roller pump being used for the hemoconcentrator displayed an error message and did not start.The pump was not used for the procedure.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 s3 roller pump being used for the hemoconcentrator displayed an error message and did not start.The pump was not used for the procedure.There was no report of patient injury.

Manufacturer Narrative

(b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).It is unknown if a livanova service representative went to the customers¿ facility to investigate the reported issue; therefore the complaint is unable to be confirmed.It was reported that the unit was installed (b)(6) 2004 and the latest maintenance was confirmed to be performed (b)(6) 2012.It is unknown how the issue was solved.No additional information received since the initial mdr was filed.Therefore, due to the age of this complaint, it will be closed.If additional information is received it will be evaluated for reportability as required.A review of the dhr did not identify any manufacturing deviations or nonconformities.Insufficient information received to determine the root cause.(b)(4) has determined that a capa is not needed to further investigate this event.

• Brand Name: S3 ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• 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: 5243124
• MDR Text Key: 31896067
• Report Number: 9611109-2015-00486
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950990
• 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: 11/24/2017

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: 10-60-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2003
• 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