MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-800

Device Problem Connection Problem (2900)

Patient Problems Exposure to Body Fluids (1745); No Patient Involvement (2645)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

According to abl800 flex operator's manual, replacing waste pump tubes should be conducted by initially entering the hold mode, which stops the solution from the waste pump to run.Date of event is best guess.

Event Description

According to the complaint, a customer got solution from waste pump into the eye.As the customer was in the process of reconnecting a y-piece for waste pump tubes, the y-piece popped off followed by solution from the waste pump splashing into the eye.

Manufacturer Narrative

Root cause investigation demonstrates that the customer reconnected waste tube back on to the y-piece followed by it popped off and splashed waste solution in the eye.Thus, the user did not follow radiometer medical's instructions.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: soeren madsen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7734128
• MDR Text Key: 115526884
• Report Number: 3002807968-2018-00050
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R1577N001R
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2013
• 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