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 01/21/2017

Event Type  malfunction  

Manufacturer Narrative

The solution pack was taken to the local radiometer office and opened.It could be seen that the waste pouch had leaked out and was empty.Most of the liquid was contained within the outer case of the solution pack but there was some on the outside as well.The data logs has been sent to radiometer medical for investigation together with photos of the interior of the solution pack.

Event Description

According to the customer the solution pack had leaked all over the analyzer and bench and the analyzer was requesting a replacement.The solution pack was taken to the radiometer office and opened.It could be seen that the waste pouch had leaked out and was empty.Most of the liquid was contained within the outer case of the solution pack but there was some on the outside as well.The analyser is used for animal blood.The operator wore glove and the incident did not cause harm to anyone.

Manufacturer Narrative

Analyzer: from the activity log it is confirmed that the analyzer was working as intended.The message "leak current in relation to solution pack detected" was logged 10 times during the period from the installation of the solution pack until event date (b)(6) 2017.Solution pack: the root cause is inconclusive since it was not possible to get either solution pack or the waste bag back from the local radiometer office to radiometer medical for investigation.

• 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: 6328681
• MDR Text Key: 67385273
• Report Number: 3002807968-2017-00004
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577(17)170401(10)XV06
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K132691
• 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,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2017
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: XV-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1