Merge Hemo 10.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842000100430), received between Jul 8, 2020 and Oct 28, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “No Device Output” (3 reports).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Jul 23, 2021Terminated

   The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.

   Z-2387-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2020No Device Output; Unintended Application Program Shut Down; No Device Output; Unintended Application Program Shut Down

  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) 2020, A CUSTOMER NOTIFIED MERGE HEALTHCARE SUPPORT THAT A POPPING NOISE WAS HEARD AND THEN SMOKE WAS SMELLED CLOSE TO THE MERGE HEMODYNAMICS UNIT IN THE SITE'S EP LAB. THE CUSTOMER FURTHER REPORTED TO SUPPORT THAT THE PHILLIPS DISPLAY MONITOR, WHICH IS THIRD PARTY HARDWARE, STOPPED WORKING AT THE SAME TIME. TECH SUPPORT INSTRUCTED THE CUSTOMER TO SWAP OUT A VGA VIDEO SPLITTER FROM ANOTHER LAB WHILE WAITING FOR REPLACEMENT HARDWARE. THIS HAPPENED AT THE VERY END OF THE CASE AND THE PATIENT WAS NOT AFFECTED. THE CUSTOMER WAS ABLE TO FINISH THE CASE PRIOR TO THE ISSUE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10751459 ↗
• MalfunctionJul 13, 2020No Device Output; Communication or Transmission Problem; No Device Output; Communication or Transmission 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. THE REPLACEMENT VGA SPLITTER FROM 2183926-2020-00023 HAS THE SAME ISSUE AFTER INSTALLATION ATTEMPT ON (B)(6) 2020. THIS WAS AN OUT OF BOX FAILURE SO THERE WAS NO PATIENT INVOLVEMENT. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10268265 ↗
• MalfunctionJul 8, 2020No Device Output; Communication or Transmission Problem; No Device Output; Communication or Transmission 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) 2020, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT A VGA SPLITTER BECAME VERY HOT AND DID NOT PRODUCE A VIDEO OUTPUT SIGNAL UPON ATTEMPT TO INSTALL ON THE SAME DAY. THIS WAS AN OUT OF BOX FAILURE SO THERE WAS NO PATIENT INVOLVEMENT. A REPLACEMENT 4 PORT VGA VIDEO SPLITTER EXTENDER WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2020. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10247349 ↗

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-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