MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I; GAS-MACHINE, ANESTHESIA

Model Number FLOW-I C20

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that a successful leakage test was performed before the case start but in some way, the breathing circuit after the test had been incorrectly connected.There are clinical alarms that are likely to have been caused by the inspiratory limb being connected to the afgo outlet instead of the patient cassette.There are no recordings in the technical log which suggests that there were any device malfunctions during the event.The connections to the inspiratory outlet, expiratory inlet and the afgo port on the anesthesia workstation are clearly marked with text and symbols to show where to connect the breathing circuit tubes.The different symbols are also described in the user¿s manual.This failure will be detected during system checkout if the breathing circuit tubes are incorrectly connected during the test.Our conclusion is that the cause of the reported issue was user error.

Event Description

It was reported that while in use on a patient, in the beginning of the case, the staff noticed that the inspiratory limb of the patient circuit had been applied to the afgo outlet at some point.There was no patient harm.(b)(4).

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 10256833
• MDR Text Key: 198323434
• Report Number: 8010042-2020-00423
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2020

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: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1