MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90; ABL90 FLEX SOLUTION PACK

Model Number	944-157
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The solution pack gave a leaking pack error.When the user removed the solution pack from the analyzer there was a pool of pink liquid on the bottom of the analyzer.When the user lifted the solution pack, pink liquid poured out everywhere on the floor.Inspection of the solution pack showed that the pink solution came from the waste pouch which contains waste liquid including blood.Nobody came into contact with the solution.
Additional Manufacturer Narrative
Investigation showed that the root cause to this incident is a manufacturing error: during mounting, the waste bag (#9) was not in the correct position and by actuation of the solution pack the waste needle did not go into the waste bag.During operation of the analyzer, wasted liquid did not go into the waste bag but ended in the box.Leak current alarm indicated the leakage.This is a resubmission of a report submitted on 02/17/2017.In the original report mfr report# was incorrect.The date of this report is the date the original report was submitted.

• Brand Name: ABL90 FLEX SP90
• Common Device Name: ABL90 FLEX SOLUTION PACK
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 6197961
• Report Number: 3002807968-2016-00044
• Device Sequence Number: 10952211
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577(17)170208(10)XR10
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 02/08/2017
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: XR10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2016
• Supplement Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1