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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH1

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The potential impact to a patient has been reviewed and the severity level has been assessed as medium (non-serious injury).During troubleshooting activities between merge technical support and the customer, it was reported that the customer tested the unit with the provided manufacturer's test plug.When the test plug was turned to 30 the unit displayed 3; when the test plug was turned to 50 the unit displayed 5.Merge technical support then shipped the customer a replacement nellcor pdm (patient data module, reference rma # (b)(4)).The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 13aug2018.The manufacturer's evaluation results showed that the customer's reported problem, pressure ports 1 and 2 were reading 1/10 off, could not be duplicated.However, a worn nibp pump and damaged top cover were found and subsequently replaced.The nibp and top cover issues would not cause the issue reported by the customer.The unit was recertified by the manufacturer and returned to merge healthcare.Upon receipt, merge healthcare tested the unit according to hemo patient data monitor test procedure (hemo-5927) and passed.Upon installation of the pdm at the customer site, it was reported that the pressure values were still displaying 1/10 off.Merge technical support instructed the customer to test the replacement unit with the manufacturer's test plug, and the pressure values displayed negative numbers.Merge technical support then instructed the customer to remove the auxillary cable and then the pressure values were displayed correctly.Merge technical support then shipped the customer a replacement link assembly (rma #(b)(4)) on 01aug2018.The faulty unit was returned to merge healthcare on 07aug2018 for evaluation.The results showed that cardiac output (co) y-cable was faulty and subsequently replaced.The unit ran overnight without issue and was then tested according to hemo patient data monitor test procedure (hemo-5927) and passed.The customer confirmed that the issue was resolved on (b)(6) 2018.A review of the customer's hemo case management within merge healthcare's internal database found that there have been no other reports of this issue as of 22aug2018.Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence as noted in the calculation section and provides the formula so that manual calculation can be performed by the user."the cardiac output measurement is calculated by the thermodilution method.The cardiac output formula is based on the well-known published stewart-hamilton formula2, 8, 9." no further actions are anticipated at this time due to the issue being readily apparent to the user, troubleshooting information provided in the user manual (formula for manual calculation), the potential non-serious impact to a patient, and the multiple labs available for use at the site.Device availability: the date used, (b)(6) 2018, was for the last piece of hardware received by the customer.(b)(4).Results: degradation problem identified (problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion) conclusions: cause traced to component failure.

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) 2018, a customer reported to merge healthcare that pressure ports 1 and 2 on the pdm (patient data module) in the site's cath lab 3 were displaying pressure values that were 1/10 off from the correct value.This occurred during a procedure and resulted in the use of a third party monitoring system.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.However, the customer confirmed that the procedure was completed successfully using third party equipment.(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: 7831479
• MDR Text Key: 118884631
• Report Number: 2183926-2018-00080
• 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: 07/31/2018

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
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3 PATCH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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