MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-85

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A serial readout of the pump has been provided to livanova (b)(4) for further evaluation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that a s5 control panel mrp lost power during a procedure.The device was restarted but it lost power again.The user decided to continue the procedure without the pump, which was being used as a suction pump.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).During evaluation of the readout, the reported issue was confirmed.Many cpu clock deviation errors were identified.It was recommended to replace the pcb hkr 0325 (90-305-620).Livanova (b)(6) decided to return the complete s5 control panel mrp 85 to livanova (b)(4) for further investigation, where the reported issue was confirmed again and a defective pcb hkr 0325 was identified as the cause.The voltage regulator was short-circuited due to contamination (soldering flux residue).The device was repaired and subsequent functional testing and technical safety inspection were successfully completed.The device was returned to the customer.Corrective actions have been implemented for this type of issue.

• Brand Name: S5 CONTROL PANEL MRP
• 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 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6522139
• MDR Text Key: 74053736
• Report Number: 9611109-2017-00314
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900825
• UDI-Public: 010403381790082511151110
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-95-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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