MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SOLUTION PACK - SP90; SOLUTION PACK - SP90 XL

Model Number 944-457

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2017

Event Type  malfunction  

Event Description

According to the complaint, the solution pack burst and started to leak, when it was removed from the abl90 flex analyzer.Fluid was on the desk top and on the floor.The solution pack has been disposed.

Manufacturer Narrative

The production journal for 944-197, yp53 r0129 was checked.No deviation according to this sample was observed.Reference sample was checked.No deviation according to this sample was observed.The root cause could not be identified in this case due to lack of investigation on defective product which has been discarded.

• Brand Name: SOLUTION PACK - SP90
• Type of Device: SOLUTION PACK - SP90 XL
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: david kawiecki ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 6960656
• MDR Text Key: 90634311
• Report Number: 3002807968-2017-00037
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/30/2018
• Device Model Number: 944-457
• Device Catalogue Number: 944-457
• Device Lot Number: YR-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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