MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

According to received information from our field service engineer, the personnel had forgot to secure the patient cassette by setting the patient cassette locking mechanism in locked position prior to use.This resulted in the patient cassette becoming slightly dislodged from the original position when changing the co2 absorber during ongoing surgery and thus creating a leakage.No parts needed to be replaced.There are no device logs available to confirm the reported event.Our conclusion is that the event was caused by the user not securing the patient cassette properly, i.E.User error.The leakage is detected by the system and alarms to alert the user are generated.(b)(4).

Event Description

It was reported that during patient treatment, when the co2 absorber was changed, the patient cassette became slightly dislodged from its original position and thus causing a leakage.There was no patient harm reported.(b)(4).

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 8178763
• MDR Text Key: 131006030
• Report Number: 8010042-2018-00682
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: No
• 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