Merge Hemo 10.4Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00842000100966), received between Sep 24, 2024 and Dec 26, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON (B)(6) 2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED: HEART RATE REPORTING AS 4 BEAT PER MINUTE (BPM), ACTUAL HEART RATE 70 BPM. MERGE HEALTHCARE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER FOR THIS EVENT. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021139 ↗
• MalfunctionSep 25, 2024Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT THE CLIENT/DOCUMENTATION SIDE OF THE DEVICE HAD A SPINNING WHEEL ON THE SCREEN DURING A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION PROCEDURE. MERGE HEMO CONTINUED TO DISPLAY AND UPDATE THE PATIENT'S VITAL SIGNS. THE USER, A REGISTERED NURSE, WAITED APPROXIMATELY FOUR MINUTES AND THEN REBOOTED THE CLIENT/DOCUMENTATION PC SO THAT DOCUMENTING THE PROCEDURE COULD CONTINUE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE, BASED ON WHAT THE CUSTOMER PROVIDED IN THE MEDSUN REPORT. IT APPEARS THAT THE SPINNING WHEEL ISSUE PROBABLY OCCURRED DUE TO A SOFTWARE DEFECT. MERGE HEALTHCARE IS WORKING WITH THE CUSTOMER TO PROVIDE A SOFTWARE UPDATE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300213 ↗
• MalfunctionSep 25, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED NO VALUE FOR HEART RATE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. USER WAS ABLE TO GET AN ACCURATE HEART RATE AFTER CHANGING LEADS MULTIPLE TIMES. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300207 ↗
• MalfunctionSep 25, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE MULTIPLE TIMES DURING A PERIPHERALLY INSERTED CENTRAL CATHETER MID-SEGMENT OF THE LEFT ANTERIOR DECENDING ARTERY PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300194 ↗
• MalfunctionSep 24, 2024Failure to Zero; Improper or Incorrect Procedure or Method; Pressure Problem; Failure to Zero; Improper or Incorrect Procedure or Method; Pressure Problem

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT A USER WAS UNABLE TO ZERO PRESSURES DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. ACCORDING TO THE CUSTOMER, THE PROCEDURE WAS DELAYED BY SEVEN MINUTES. MERGE HEALTHCARE HAS BEEN WORKING WITH THE CUSTOMER TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN CONFIRMED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297463 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE DURING A PACEMAKER INSERTION PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8017

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297461 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE DURING A CATH LAB PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297269 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Unintended Application Program Shut Down; Computer Software Problem; Unintended Application Program Shut Down

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT THE CLIENT/DOCUMENTATION SIDE OF THE DEVICE SHUT DOWN DURING A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION PROCEDURE. THE PHYSICIAN WAS ABLE TO PROCEED WITH THE PROCEDURE AND CARE FOR THE PATIENT BECAUSE MERGE HEMO CONTINUED TO DISPLAY AND UPDATE THE PATIENT'S VITAL SIGNS THROUGHOUT THE PROCEDURE. THE CUSTOMER RELOGGED INTO THE MERGE HEMO CLIENT SO THAT DOCUMENTING COULD CONTINUE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE AND DETERMINED THAT THIS ISSUE OCCURRED DUE TO A SOFTWARE DEFECT. MERGE HEALTHCARE IS WORKING WITH THE CUSTOMER TO PROVIDE A SOFTWARE UPDATE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297252 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND NO PULSE OXIMETER/SPO2 VALUE DURING A DUAL CHAMBER PACEMAKER PLACEMENT PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297230 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND NO PULSE OXIMETER/SPO2 VALUE DURING AN IMPELLA PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297204 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297203 ↗
• MalfunctionSep 24, 2024Computer Operating System Problem; Computer Operating System Problem

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE REPORTED THAT DURING PROCEDURE ROOM PREPARATION ACTIVITIES, THE MERGE HEMO DEVICE'S KEYBOARD AND MOUSE WERE UNRESPONSIVE. MERGE HEMO HAS TOUCHSCREENS AS ANOTHER INTERFACE OPTION BESIDES A KEYBOARD AND MOUSE. HOWEVER, DUE TO THE INABILITY TO USE A KEYBOARD AND MOUSE WITH MERGE HEMO, PATIENT PROCEDURES WERE PERFORMED IN OTHER LABS ONSITE. MERGE HEALTHCARE TECHNICAL SUPPORT REMOTELY CONNECTED TO THE AFFECTED SYSTEM AND CONFIRMED THAT THE CLIENT PC'S USB PORTS WERE NOT COMMUNICATING. A REPLACEMENT PC WAS SHIPPED OVERNIGHT AND A RETURN MATERIAL AUTHORIZATION (RMA) WAS INITIATED FOR THE DEFECTIVE PC. PER POLICY, EQUIPMENT RETURNED FROM CLIENTS IS WIPED PRIOR TO PERFORMING SYSTEM DIAGNOSTICS TO PROTECT PATIENT INFORMATION. AFTER WIPING THE DRIVE AND REINSTALLING THE OPERATING SYSTEM, DIAGNOSTIC TESTS WERE PERFORMED AND THE USB PORTS WERE FOUND TO BE FUNCTIONAL. HENCE, THE ROOT CAUSE OF THIS ISSUE IS UNKNOWN. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297199 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT A USER WAS UNABLE TO SEND COMPLETED CARDIAC CATHETERIZATION PATIENT REPORTS TO THE EMR POST PROCEDURE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE AND DETERMINED THAT THE INABILITY TO SEND REPORTS TO THE EMR WAS CAUSED BY A POLICY CHANGE WITHIN THE CUSTOMER'S ENVIRONMENT THAT AFFECTED FILE PERMISSIONS. WITHOUT THE APPROPRIATE FILE PERMISSIONS, PATIENT REPORTS CANNOT BE CREATED AND TRANSFERRED TO THE EMR. TO RESOLVE THE ISSUE, MERGE TECHNICAL SUPPORT RESTORED THE FILE PERMISSIONS WITHIN THE CUSTOMER'S ENVIRONMENT. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297158 ↗
• MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND BLANK OR ZERO SPO2 VALUES DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293279 ↗

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