MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 PUMP HEAD; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 50-40-60

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the s3 pump head.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

(b)(4) received a report that the nominal-actual comparison of the s3 pump head of the double head pump failed during priming.There was no patient involvement.

Manufacturer Narrative

A livanova field service representative was dispatched to investigate.The service representative found the board to be defective.The board was replaced.The unit was cleaned and disinfected.Functional checks were carried out and all modules and devices operated as expected.A review of the dhr could not identify any deviations or nonconformities.

• Brand Name: S3 PUMP HEAD
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6485818
• MDR Text Key: 72552779
• Report Number: 9611109-2017-00293
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/15/2018

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: 50-40-60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 03/15/2017
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611109-2017-00293
• Patient Sequence Number: 1