MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	MERGE HEMODYNAMICS 10.3
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
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 can be entered by the user and displayed by the system.If desired and using a third party database the hemo system can display drug to drug or drug to allergy interaction information.The system is intended for use in hospital cardiac catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.On 4/22/2021, internal testing revealed that the custom hl7 lab mapping functionality within merge hemo was mapping lab values improperly.At the time of the discovery, with the information available, the issue was deemed not to be reportable.However, after an internal meeting on 6/22/2021, additional information became available, and the issue was deemed to be reportable.There have been no customer reports of this issue.A supplemental report will be filed when more information becomes available.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaints (b)(4).
Additional Manufacturer Narrative
This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 7/15/2021.Recall z-2387-2021, 2183926-07/21/2021-001-c, res 88379 for merge hemo versions 10.2, 10.3 and 10.4, when upgraded from merge hemo versions 9.X and 10.X, used in combination with an hl7 lab interface, initiated to address the incorrect mapping of lab values from custom fields, was successfully initiated, completed, and submitted for closure to the agency as of 12/22/2021.There have been no reports of patient injury or harm as a result of this issue.No additional action is necessary at this time/ reference complaints (b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: brian bell ; 75 binney street; cambridge, MA 02142-1123 ; 3123540189
• MDR Report Key: 12178358
• Report Number: 2183926-2021-00016
• Device Sequence Number: 1621876
• Product Code: DQK
• UDI-Device Identifier: 00842000100874
• UDI-Public: (01)00842000100874(10)10.3.0(11)200330
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: MERGE HEMODYNAMICS 10.3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2387-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown