S5 Double Roller Pump 85 DRP 85 (UDI 04033817902737)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04033817902737), received between Sep 9, 2022 and Nov 13, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672345 ↗
• MalfunctionAug 28, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED A REPORT ABOUT CONSOLE ALARMS WITH "FAULT IN MOTOR CONTROLLER (431) PUMP 2A (BLOOD) , FAULT IN MOTOR CONTROLLER (433) PUMP 2A (BLOOD) AND FAULT IN MOTOR CONTROLLER (442) PUMP 2A (BLOOD)" WHEN TURNED ON. THE FIELD SERVICE ENGINEER HAS DONE THE SWAPPING PROCESS WITH OTHER SPARE PARTS TO DETERMINE WHICH SPARE PARTS ARE DAMAGED. IT WAS CONCLUDED THAT THE DAMAGE WAS ON THE POWER AMPLIFIER MOTOR BOARD AND THE ROLLER PUMP 85 PUMP HEAD ROTOR IN PUMP 2A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085551 ↗
• MalfunctionOct 31, 2023Device Alarm System; Device Alarm System

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE ROLLER PUMP 85 TWIN PUMPS WENT IN A RUNAWAY STATE. PUMPS DISPLAYED ERROR CODE 1A AND ERROR INDICATING THAT PUMP SPINNING IN THE OPPOSITE DIRECTION. THE ISSUES OCCURRED DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038950 ↗
• MalfunctionJun 19, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150168 ↗
• MalfunctionSep 9, 2022Decreased Pump Speed; Decreased Pump Speed

  LIVANOVA RECEIVED REPORT THAT A S5 DOUBLE ROLLER PUMP FAILED DURING PRIMING. WHILE SETTING UP THE PERFUSIONIST CHECKED THE OCCLUSION ON THE SMALL ROLLER PUMP AND THEN TURNED THE PUMP RPMS TO 0. AFTER FINISHING UP WITH PREPARING FOR THE CASE HE NOTICED THAT THE SCREEN SHOWED DASHES AND NO LONGER READ 0.00 LPM AND RPM. A PICTURE WAS PROVIDED. THE PUMP WAS RESTARTED MULTIPLE TIMES AND PLUGGED IT INTO DIFFERENT PORTS ON THE BASE OF THE S5. HOWEVER, THE ISSUE PERSISTED AND ANOTHER ROLLER PUMP WAS USED FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15388906 ↗