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

Model Number	944-157
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solution pack was used in a abl90 flex plus analyzer (item no.393-092, serial no.(b)(4).
Event or Problem Description
According to the complaint the user found a lot of liquid leakage from the solution pack(sp) several days after the 90sp was installed.Nobody touched the leaked liquid directly.The sp contained contaminated blood.
Additional Manufacturer Narrative
G4: corrected data: device is not a combination product.H3: the concerned solution pack was available to be returned to radiometer for investigation purposes, but as the solution pack contained contaminated blood it was disassembled at distributor site and pictures of this was used at radiometer investigation.H6: component code has not been filled out as the root cause investigation indicates that the device did not malfunction.For the radiometer investigation investigator checked production documentation e.G.The production journal.Logbook's related to ready good productions process was verified.None of them were linked to registered complaint.Reference samples were also checked and reference sample was mounted in accordance to specification.The finalized radiometer investigation identified the root cause for the event as a waste pouch component issue and also the process of assembly at the radiometer production site.To solve the complaint issue the user/customer shall change the solution pack to a new solution pack.

• Brand Name: ABL90 FLEX SOLUTION PACK SP90
• Common Device Name: ABL90 FLEX SOLUTION PACK SP90
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 10761727
• Report Number: 3002807968-2020-00047
• Device Sequence Number: 3385136
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577(17)210120(10)IY77
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 01/20/2021
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: LOT IY-77
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1