Merge HEMO 10.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842000100034), received between Jun 12, 2018 and Aug 24, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K152864); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021No Device Output; No Device Output

  MERGE HEMO DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE HEMO SYSTEM CAN VISUALIZE AND CAPTURE VITAL SIGN VALUES INCLUDING ECG, IMPEDANCE RESPIRATION, SPO2 AND PLETH WAVEFORMS, INVASIVE BLOOD PRESSURE, TEMPERATURE, NON-INVASIVE BLOOD PRESSURE (NIBP), THERMODILUTION CARDIAC OUTPUT AND FRACTIONAL FLOW RESERVE (FFR). THE SYSTEM CAN DISPLAY AND CAPTURE DIAGNOSTIC QUALITY 12 LEAD RESTING ECG TO VISUALIZE ARRHYTHMIAS, AND ST-SEGMENT CHANGES. SOME HEMO SYSTEMS HAVE AN OPTION TO MEASURE AND DISPLAY SIDE-STREAM END TIDAL CARBON DIOXIDE (ETCO2) ALONG WITH APNEA AND RESPIRATION RATES CALCULATED FROM THE ETCO2 WAVEFORM. THE HEMODYNAMIC PORTION OF THE SYSTEM IS COMPRISED OF THE PATIENT DATA MODULE (PDM) AND THE MERGE HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS ARE ACQUIRED AND CALCULATED IN THE PDM. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN THEN BE DISPLAYED ON THE MERGE HEMO MONITOR PC. THE MERGE HEMO SYSTEM IS NOT INTENDED TO PRODUCE ALARMS FOR OUT-OF-RANGE CONDITIONS. PATIENT ALLERGIES AND CURRENT MEDICATION INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362826 ↗
• MalfunctionJul 16, 2019Power Problem; Power Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2019, A CUSTOMER CONTACT REPORTED TO MERGE HEALTHCARE THAT DURING A CASE, THE LAB FROZE, BEEPING WAS HEARD FROM THE PATIENT DATA MODULE (PDM), AND THE HEMO SYSTEM BOOTED USERS OUT. THEY HAD TO REBOOT THE COMPUTER SEVERAL TIMES. SUBSEQUENTLY, THE PATIENT HAD TO BE MOVED TO ANOTHER LAB TO COMPLETE THE CASE. INITIAL TROUBLESHOOTING REVEALED THAT THE 12 VOLT WAS OUT ON THE HEMO PC. IN ADDITION, THE CUSTOMER STATED THAT THE PCI CARD WAS FRAYED. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE WAS A DELAY IN TREATMENT/DIAGNOSIS THAT COULD POTENTIALLY CAUSE HARM TO THE PATIENT. HOWEVER, THERE WAS NO ALLEGATION OF HARM OR INJURY TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793254 ↗
• MalfunctionAug 21, 2018Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, THE CUSTOMER CONTACT REPORTED THAT THE HEMO MONITOR PC WAS FREEZING IN LAB 1. THE CUSTOMER FURTHER REPORTED THAT THE FREEZING ISSUE OCCURRED PRIOR TO, DURING, AND AFTER PROCEDURES WERE COMPLETED. PER THE CUSTOMER, IN SOME CASES, THE HEMO MONITOR WOULD FREEZE FOR JUST A SECOND AND THEN CONTINUE AND FREEZE MULTIPLE TIMES THROUGHOUT THE PROCEDURE. IN OTHER CASES, THE FREEZING WOULD OCCUR UP TO 15 TIMES FOR AS LONG AS 10 MINUTES. AS A RESULT OF THE FREEZING, THE HEMO MONITOR PC WOULD BE REBOOTED DURING SOME PROCEDURES, AND A THIRD PARTY MONITORING DEVICE WOULD BE USED. THE PROCEDURES WERE THEN COMPLETED SUCCESSFULLY. THERE WAS N

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7801522 ↗
• MalfunctionJun 12, 2018Communication or Transmission Problem; Noise, Audible; Communication or Transmission Problem; Noise, Audible

  MERGE HEMODYNAMICS DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2018, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THE PDM (PATIENT DATA MODULE) STARTED ALARMING AND NO PATIENT VITALS WERE DISPLAYED IN THE MIDDLE OF A PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS MOVED TO ANOTHER LAB. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR DELAY IN TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. HOWEVER, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY ONCE THE PATIENT WAS MOVED TO A KNOWN WORKING LAB. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152864. One submission often covers many models, so check the product and lot details in each record.

• Z-2387-2021 · Jul 23, 2021 · Terminated
  Merge Hemo, Software packages 10.2, 10.3, and 10.4
• Z-0350-2018 · Apr 6, 2017 · Terminated
  Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo Syste