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 Not Applicable (3189)

Event Type  malfunction  

Event Description

When the technician replaced the solution pack for the abl90 he found solution leaking from the solution pack.Info on the exact amount of leaking solution is not available.It is possible that the leaking solution is waste which consist of solution pack liquids and blood from pt samples.The user got liquid on the clothes but it is not known if there was any contact with the skin.No pts were involved in this incident.

Manufacturer Narrative

The solution pack will be sent radiometer medical for investigation.The result of this investigation 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; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj 2100 ; 8273827
• MDR Report Key: 4189875
• MDR Text Key: 5026456
• Report Number: 3002807968-2014-00045
• 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: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• 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: 09/16/2014
• 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