MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SCP FLOW SENSOR 3/8"; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 96-414-120

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the scp flow sensor 3/8".The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4) a replacement flow sensor has been provided to the customer and the defective sensor has been scrapped.No further investigation is possible.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device has been scrapped.

Event Description

(b)(4) received a report that the scp flow sensor 3/8" was found to be faulty during priming.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the scp flow sensor 3/8".The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).In the initial report, submitted august 25, 2017, it was stated that the replaced scp flow sensor 3/8" was scrapped and no further investigation was possible.This information was incorrect.The flow sensor was returned to livanova (b)(4) for investigation.During testing in a climate chamber at an elevated temperature and humidity, the sensor was no longer able to read flow and only displayed dashes.This was a repeatable malfunction.Based on the production date of the device, the most likely root cause of the reported issue was determined to be the age of the device.The sensor was scrapped upon completion of the investigation.

• Brand Name: SCP FLOW SENSOR 3/8"
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 6822370
• MDR Text Key: 83747736
• Report Number: 9611109-2017-00666
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011838
• 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: 09/25/2017

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: 96-414-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2008
• 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