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

Model Number 944-157

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

The solution pack has been returned to radiometer for investigation.Investigation shows that the leakage was caused by incorrect installation of waste pouch during manufacturing.According to the data logs the analyzer gave a warnings several days before the incident: 963/964 leak current - replace sp.

Event Description

On (b)(6) 2017 the customer changed the solution pack (sp) on their abl90 analyzer.The used sp was placed on a bench whilst the new one was installed on the analyzer.When the customer went to pick up the used sp to put it in the bin, the waste pouch inside burst and waste fluid leaked out all over the floor and onto the customer.The sp came from a test analyzer and therefore had not been used for blood samples.Hence there was no risk of infection for the user.

• Brand Name: ABL90 FLEX SP90
• Type of Device: ABL90 FLEX SOLUTION PACK
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; åkandevej 21; brønshøj, 2100 ; DA 2100 ; 538273827
• MDR Report Key: 6300061
• MDR Text Key: 66464602
• Report Number: 3002807968-2017-00001
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: XK-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1