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S5 Mast Roller Pump Control Panel for 1 MRPRecalls & reported problems

LivaNova Deutschland GmbH · Class 2

Adverse event reports
11
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04033817900818), received between Jul 19, 2016 and Jan 3, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Pumping Stopped5
  • No Display/Image4
  • Appropriate Device Problem Term/Code Not Available1
  • Failure to Pump1
  • Insufficient Device Problem Information1
  • Loss of Power1
  • Unexpected Shutdown1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient4
  • No Patient Involvement3

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 3, 2024Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A BYPASS, WHEN MAIN PUMP (MAST RP150) REACHED FULL FLOW, THE PUMP STOPPED AND THE S5 CONTROL PANEL MRP 150/85 CONTROL PANEL SCREEN WENT BLACK. THE USER TRIED TO SWITCH OFF AND ON THE MAST PUMP CONTROL PANEL AND IT DIDN'T RESTART. THE OTHER PUMPS WERE FUNCTIONING AND THE DISPLAY PANEL WAS FINE. THE USER ELECTED TO REPLACE THE WHOLE S5 UNIT TO ANOTHER STANDBY UNIT. THERE IS NO REPORT OF ANY PATIENT INJURY. LATER WHEN THEY RESTARTED THE S5 SYSTEM, THE MAST ROLLER PUMP TURNS ON AGAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18433428 ↗
  • MalfunctionAug 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A S5 MAST ROLLER PUMP DEFECT. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CASE HAS BEEN CONSERVATIVELY EVALUATED AS REPORTABLE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15147124 ↗
  • MalfunctionJun 3, 2022Unexpected Shutdown; Unexpected Shutdown

    LIVANOVA RECEIVED REPORT THAT THE CONTROL PANEL OF A S5 MAST ROLLER PUMP (MRP) TURNED OFF DURING THE SETUP FOR A CASE. THE BIOMEDICAL ENGINEER OF THE HOSPITAL TOGGLED THE POWER SWITCH ON AND OFF MULTIPLE TIMES ON THE MRP CONTROL PANEL, BUT THE DISPLAY NEVER CAME BACK ON. THE BIOMEDICAL ENGINEER THEN MOVED THE MRP CONTROL PANEL CABLE FROM PORT 10 TO PORT 12 ON THE EP PACK. THIS SEEMED TO CORRECT THE ISSUE AND RESTORED POWER TO THE MRP CONTROL PANEL. IT WAS ASSUMED THAT PORT 10 ON THE EP PACK WAS FAULTY. IT WAS REPORTED THAT IT IS UNKNOWN IF THE PUMP HAD ALSO LOST POWER OR JUST THE DISPLAY ON THE MRP CONTROL PANEL, BECAUSE THE PUMP WAS NOT IN USE AT THE TIME OF THIS FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14596527 ↗
  • MalfunctionJan 21, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 MAST ROLLER PUMP STOPPED SEVERAL TIMES DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13313103 ↗
  • MalfunctionMay 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 CONTROL PANEL MRP 150/85 WAS NOT WORKING DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8615199 ↗
  • MalfunctionAug 3, 2018No Display/Image; Pumping Stopped; No Display/Image; Pumping Stopped

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 CONTROL PANEL MRP BECAME BLANK AND THE PUMP STOPPED DURING PROCEDURE. THE CUSTOMER RESTARTED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7746246 ↗
  • MalfunctionJul 27, 2018Loss of Power; Pumping Stopped; Loss of Power; Pumping Stopped

    LIVANOVA (B)(4) RECEIVED A REPORT THAT AN S5 CONTROL PANEL MRP LOST POWER DURING PRIMING. THIS POWER LOSS LED TO A STOP OF THE MAST ROLLER PUMP. THE CUSTOMER RESTARTED THE S5 SYSTEM TO RESOLVE THE REPORTED ISSUE. HOWEVER, THE REPORTED FAILURE RECURRED WHEN SWITCHING TO ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7728983 ↗
  • MalfunctionJul 17, 2018No Display/Image; No Display/Image

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF AN S5 CONTROL PANEL DID NOT POWER UP DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7696820 ↗
  • MalfunctionDec 28, 2017No Display/Image; No Display/Image

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE DISPLAY OF AN S5 CONTROL PANAL MRP BECAME BLANK DURING A PROCEDURE AND THE USER WAS UNABLE TO CONTROL THE PUMP. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7151632 ↗
  • MalfunctionDec 1, 2017No Display/Image; No Display/Image

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 CONTROL PANEL CONTROL PANEL MRP GOT BLACK DURING PROCEDURE. THE CUSTOMER WAS NOT ABLE TO CONTROL THE PUMP HEAD DUE TO THIS ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7074192 ↗
  • MalfunctionJul 19, 2016Failure to Pump; Pumping Stopped; Failure to Pump; Pumping Stopped

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PUMP STOP MESSAGE APPEARED ON THE S5 CONTROL PANEL MAST ROLLER PUMP DURING IN-SERVICE WHEN USING PUMP #1, AND THE PUMP FOR STOP LINK COULD NOT BE ACCESSED WHEN PUMP #1 WAS SELECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 5807457 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.