CP5 Emergency SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04033817900955), received between Oct 20, 2022 and Aug 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K112225); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 30, 2017Terminated

   Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.

   Z-0401-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Infusion or Flow Problem; Infusion or Flow Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING PROCEDURE, FOLLOWING SUDDEN POWER FAILURE IN THE HOSPITAL, CENTRIFUGAL PUMP 5 (CP5) COULD NOT ROTATE. THEN, HAND-CRANK PROCEDURE WAS PERFORMED, BUT THE CENTRIFUGAL PUMP CONTINUED TO NOT ROTATE AND THE EFFECTIVE BLOOD FLOW COULD NOT BE ACHIEVED; RAISED THE DROP SPEED OF NOREPINEPHRINE AND THE OXYGEN CONCENTRATION OF THE VENTILATOR. AFTER THE MAIN POWER SUPPLY REGAINED, CENTRIFUGAL PUMP WAS PUT INTO S5 MACHINE AND THE OPERATION STARTED AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17448712 ↗
• MalfunctionOct 20, 2022Break; Break

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A FAILURE OCCURRED DURING HAND CRANK PROCESS WITH A CP5 EMERGENCY DRIVE UNIT . REPORTEDLY, THE TRANSMISSION OF THE MOVEMENT WAS NOT POSSIBLE APPARENTLY FOR DECOUPLING OF THE WIRE. THE CUSTOMER SHARED PHOTOS AND VIDEO OF THE ISSUE SHOWING THE DAMAGE OF THE WIRE COVER AND STATED THAT DEVICE WAS NOT HANDLED BADLY AND IT WAS NOT STORED IN BAD CONDITIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638118 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112225. One submission often covers many models, so check the product and lot details in each record.

• Z-0787-2022 · Dec 17, 2021 · Terminated
  Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control dev
• Z-0857-2014 · Dec 4, 2013 · Terminated
  CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
• Z-1329-2012 · Feb 23, 2012 · Terminated
  Pump control panel. The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.