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

Model Number MERGE HEMODYNAMICS 10.0.3

Device Problems Failure to Transmit Record (1521); Data Problem (3196)

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

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts, the customer reported to merge technical support that the calculations provided by merge hemo were correct, however the waveforms were weak.Merge technical support advised the customer to switch out the third party catheter and to hang it from an iv pole to reduce noise and interference on the transducer.The attending physician then switched out the catheter and the procedure was completed successfully.The faulty hardware will not be received from the customer since it was third party equipment.(b)(4).

Event Description

Merge hemodynamics monitors, 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 june 30, 2017, a customer reported to merge healthcare that a problem occurred while attempting to obtain a patient's thermo co (cardiac output) readings.Subsequently, the patient was moved to another lab after sedation had been initiated to rule out faulty hemo equipment.However, the problem persisted so the attending physician removed the catheter and replaced it with a new one.With merge hemo not presenting physiological data during treatment, there is a potential for delay in care that could result in harm to the patient.However, the customer confirmed that the procedure was completed successfully once the third party catheter was changed out.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: 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: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 6753211
• MDR Text Key: 81383194
• Report Number: 2183926-2017-00159
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1