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

Model Number	944-157
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/21/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ABL90 FLEX SOLUTION PACK
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 6328681
• Report Number: 3002807968-2017-00004
• Device Sequence Number: 16343347
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577(17)170401(10)XV06
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1