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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

This issue is being further investigated by merge healthcare.A supplemental report will be submitted once the investigation is complete.[fda_medwatch_report_mw5084968].

Event Description

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, the customer contact reported that during an urgent case, pressure values were incorrect.No complicated pressures were needed therefore, a portable 3rd party system was used to complete the case.Additional information was received on (b)(6) 2019 (from medwatch report, mw5084968) stating that the pressure readings were doubled causing a patient to be transferred to another lab.Subsequently, the patient was re-prepped and the procedure was completed after a 30 minute delay.Additional access was required due to the potential for contamination from the original access site during the patient move.Please reference attached medwatch report mw5084968 for additional information.Reference complaint number (b)(4).

Manufacturer Narrative

Merge healthcare conducted an internal investigation (hemo-15460) and it was determined that installation technician assumed incorrectly that the facility had the correct v2 cables that are to be used with the v2 pdm.Since the facility has been in operation with merge hemo for >12 years, they did have old v1 cables available.This assumption by the technician resulted in the customer being told they were able to use the pdm cables they already had.V1 cables are not compatable with v2 pdms.The doubling of pressures is why schiller, the oem of the patient data module (pdm) revised the v1 cable connector in order to better align the connection from the cable to the pdm.Additionally, the customer was not aware of the difference between the v1 & v2 cables & the non-compatibility of the hardware components.While the v1 & v2 cables have different colored connectors (beige vs.Red) the cables were not labeled as v1 or v2 to better differentiate between them.The customer confirmed that the issue was resolved when the correct v2 and fractional flow reserve (ffr) cables were ordered & utilized.In addition, hemo-52 merge hemo planning guide (v9) was sent to the customer referencing page 11 regarding the use of v2 cables and v2 pdms.No further issues regarding double pressures have been noted.Per hemo-5303 merge hemo 9.40 user manual: (page 371).Thermo cardiac output.Question: what problems could occur if the wrong cable is used? answer: the system will not provide cardiac outputs if there is a mismatch; the correct cables must be used.If cardiac outputs issues arise, check for the following: the cable that attaches to the pdm should always be connected to temperature channel 1.Values should display on the hemo monitor if the cable is connected to the pdm, the swan is connected to the cable, and the probe/in-line cable is connected to the output cable.If the sample is room temperature, the value should read between 19 and 25 degrees celsius.If the displayed value is very low and an ice bath (between 0-5 degrees c) is not being used, the problem is probably that the wrong type has been chosen in the action editor.If injectant reads cable off or low<0.5 and distal reads cable off or high>43.0 either the cardiac output cable is not connected to the pdm, the swan is not connected to the cardiac output cable, or the probe/in-line cable is not connected to the cardiac output cable.All must be connected and the correct type selected in the action editor in order to get valid numbers and obtain valid cardiac outputs.After capturing the cardiac output, if the value is not in the range expected, check the constant value in the action editor.If the numeric value for the probe temperature is very high, the probe may close to an external heat source.For example, there have been situations reported in which the bath probe was placed on the table top and covered by sterile sheets; there may be a temperature build up from the patient that can affect the bath probe temperature.Per hemo-52 merge hemo planning guide (v9).(page 11).It is the hospital's responsibility to acquire the cable between the pdm and the transducers.These cables can be obtained from the hospital's transducer vendor.It is critical that these cables be available before the system is scheduled to go live.Merge healthcare currently ships the third generation of pdm referred to as the v2 pdm with new systems and add-on labs.V2 pdms must only use cables marked with a v2 label.If the installation is for an add-on lab, and the old lab has a non-v2 pdm, the cables are not interchangeable.V2 pdms must only use cables marked with a v2 label.It is also recommended that the hospital purchase an additional accessory kit that includes ecg leads, cuffs, and spo2 clip.Hh-10284 accessory kit for current version v2 pdm.Information contained in this supplemental report includes the following: date new information received by manufacturer investigation completed 6/21/2019 evaluation codes: methods code: added 4112 analysis of data provided by user/third party.Results code #1: added 3213 interoperability problem identified.Results code #2: added 4206 device not compatible with another device.Results code #3: added 150 labeling and instructions for use/maintenance.Results code #4: added 154 inadequate labeling and/or instructions for use.Conclusions code #1: added 27 cause traced to training.Conclusions code #2: added 25 cause traced to manufacturing.Conclusions code #3: 23 manufacturing deficiency.Indication of additional manufacturer information are contained in this follow-up report.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 8532155
• MDR Text Key: 145617692
• Report Number: 2183926-2019-00016
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other