MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SRD S5 SINGLE ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that the flow of the single roller pump, main pump of the s5, will return back to zero no matter how much rmp are set.

Manufacturer Narrative

Livanova deutschland manufactures the s5 roller pump.The incident occurred in taiwan.According to information, the s5 console lost power supply after the battery test was performed: all the pumps and the displays of the s5 cannot be power on.The engineer at the hospital checked the device and found that the switching power supply (item 96-403-551) and the batteries were damaged.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

H.10.The srd s5 single roller pump 150 has been took back distributor office and has been tested continuous with their s5 without any problem.No part was to be replaced.No alarm was showed in the system panel.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

During the evaluation of the serial read-out of all involved pumps (real-time device parameters and setting recording file), it was determined that a "motor not connected", reset and bus connection failure was recorded in the date of the event cause of these events can be related to hardware failures or to external causes, such as interferences from high-frequency devices.Based on the device reporting review, it is very unlikely that a hardware fault occurs on more than one pumps of the console simultaneously.However, in order to exclude this scenario, s5 console has been checked and positively tested as per tsi by the livanova field service representative.The hlm was found working as expected and within specification: no hardware or software failures could be detected during the tests performed.Based on the above facts, it was possible to exclude a hardware failure of the console.Therefore, the most likely root cause of the reported event was traced back to external interferences from high-frequency devices.It is strongly recommended to check the operating theatre and the ambient of the operating theatre for emissions of high frequency emitting devices and to always have connected the potential equalization cable to earth (see ifu, chapter 2.2.6).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: SRD S5 SINGLE ROLLER PUMP 150
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15985133
• MDR Text Key: 306260376
• Report Number: 9611109-2022-00673
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)200312
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

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: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 03/24/2023
• Supplement Dates FDA Received: 01/19/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2020
• 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