MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90

Model Number 944-157

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2017

Event Type  malfunction  

Event Description

According to the complaint, on (b)(4) 2017, a customer got the error messages below on abl90 display, and they could not measure a sample.Analyzer need maintenance.Leak current detected (#(b)(4)).The customer removed the solution pack from abl90 and re-installed it because the solution pack was fresh.They installed a new 90sp within a day.Then they found pink liquid leakage from the bottom of the solution pack.It was reported that the solution pack had a slight leak at the customer site, but it was leaking a lot at radiometer (b)(4) site.The customer did not get in contact with the leaked liquid, but an radiometer (b)(4) employee got in contact with a bit of leaking liquid when receiving the solution pack.

Manufacturer Narrative

The solution pack was leaking due to the waste pouch being misplaced 5mm forward when assembling the sp in production.When the solution pack was activated the waste needle couldn't penetrate the waste pouch, and was bent, causing waste fluid to be released to the top of the sp.

• Brand Name: ABL90 FLEX SP90
• Type of Device: ABL90 FLEX SP90
• 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: david kawiecki ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7236658
• MDR Text Key: 99773899
• Report Number: 3002807968-2018-00006
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2018
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: YW52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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