MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH MAST ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-00

Device Problem Pumping Stopped (1503)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 mast roller pump, the incident occurred in germany.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, during priming, the pump stopped and displayed a run-up error.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: device have been received at manufacturer site.Serial read out (real time device parameters and setting recording file) of the pump was collected and will be investigated.The non volatile memory (nvmem) has been cleared.Technical safety inspection together with a 24 hours run test done have been performed.Investigation to be completed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: the pump was found working properly as per specifications during the 24h run test done at manufacturing site.Results of analysis of the serial read-out (real time device parameters and setting recording file) of the involved pump found that: a bubble alarm was stored and correctly stopped the pump; the pump cover was opened by the user; a runaway alarm was recorded; the event timeout_intervention was stored and was most likely related to the improper (without unlinking it) switch off of the bubble monitoring function by the user; a second runaway alarm was recorded.The root causes of the runaway error can be any of the following: 1- pump hand cranked and not switched off by the user 2- pump manipulated and not switched off by the user; 3- hardware reset of pump (off/on); 4- defective motor control board/hall sensor in the pump head.The involved pump was manufactured in 2014 and according to the review of the complaints database no similar events have been reported in the past.Based on the analysis, it was determined that the s5 mast roller pump correctly stopped under bubble monitoring function alarming, prior to the runaway error.After the bubble alarm stopped the pump, the message cover_stop was stored and confirmed that the cover was opened by the user prior to the runaway error.Since the device correctly responded to triggers and no components have been replaced, no hardware failure of the pump was confirmed thus root causes 3 and 4 are excluded.Since the event occurred during priming, it can be excluded that user performed hand crank on the pump and thus also root cause 1 is excluded.Therefore, it is most likely that the error was consequent to manipulation of the pump head by the user (root cause 2).It is reasonable to assess that the pump stopped because of the bubble alarm (as demonstrated by the pump serial read-out) and that the pump was manipulated by the user after opening the cover.Pump manipulation without switching it off, led to the runaway error registered in the pump serial read-out.

Event Description

See initial report.

• Brand Name: MAST ROLLER PUMP 150
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 17798137
• MDR Text Key: 324027565
• Report Number: 9611109-2023-00461
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103762
• 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: 04/02/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2014
• 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