MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90

Model Number	944-157
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ABL90 FLEX SP90
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7236658
• Report Number: 3002807968-2018-00006
• Device Sequence Number: 19090717
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1