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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problem Connection Problem (2900)

Patient Problem Antibiotics, Reaction To (1713)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Merge technical support remotely accessed the workstation in question and found there was a lag in the unit's replication time, about 1 hour, prior to the customer's call in for assistance.Merge technical support adjusted the workstation settings (b)(4) and the unit began replicating correctly.It was confirmed that the customer's reported problem was resolved.Through internal investigation at merge healthcare (b)(4), a mitigation has been established for any future occurrences where the hemo client pc changes from "always connected" status to "direct connect" status.Device labeling, (b)(4) v10 user manual, addresses the potential for such an occurrence with statements such as, "direct connect workstations allow the merge hemo client to run without the need to install a local (b)(4) database; the client application communicates directly with the server." in addition, the hemo monitor pc has been designed as a separate application running on a different computer to allow users to continue to document study notes if the client pc is non-operational.Therefore, there was no risk of patient data loss.

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 (b)(6) 2016, a customer reported to merge healthcare that problems were experienced with one of the site's workstations that displayed an error message, "only connected to the server." it was further reported that the problem occurred while a patient was on the table and was subsequently removed "due to other issues" that resulted in the procedure being cancelled and then rescheduled for a later date.Information obtained from the customer revealed that the patient was removed from the table due to an allergic reaction to vancomycin.(vancomycin is used as a prophylactic in heart catheterization procedures.) the patient's blood pressure and heart rate dropped and then presented with hypertension and itching; the patient was administered (b)(6).With merge hemo not operating as expected there is a potential for harm that may lead to a serious injury or death.However, the customer further reported that the patient returned on (b)(6) 2016 to have the procedure done and it was completed successfully without complications.(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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6231540
• MDR Text Key: 64125981
• Report Number: 2183926-2017-00002
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other