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

Model Number ABL90 SOLUTION PACK

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2014

Event Type  malfunction  

Event Description

When the technician replaced the solution pack for the abl90 he found a lot of solution leaking from the solution pack.Information on the exact amount of leaking solution is not available.It is possible that the solution is waste which consist of solution pack liquids and blood from patient samples.Nobody came in contact with the solution and no patient was involved in this incident.

Manufacturer Narrative

It is being investigated if the incident was caused by malfunction of the device or by a user error.Data logs from the analyzer have been received and will be analyzed.The data logs can show which, if any, error messages have been displayed on the analyzer.The result of the investigation of the data logs will be included in the final report.

• Brand Name: ABL90 FLEX SOLUTION PACK
• Type of Device: ABL90 SOLUTION PACK
• Manufacturer (Section D): RADIOMETER MEDICAL APS; 2700 bronshoj; DA
• Manufacturer Contact: akandevej 21; bronshoj ; 8273827
• MDR Report Key: 4058779
• MDR Text Key: 18368958
• Report Number: 3002807968-2014-00034
• Device Sequence Number: 1
• Product Code: CHL
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABL90 SOLUTION PACK
• Device Catalogue Number: 944-157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1