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

Model Number 944-157

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Solution pack discarded by user.

Event Description

According to the complaint, on (b)(6) 2017 while changing the abl90 flex plus analyzer solution pack, the solution (including blood) leaked over the operator.No reports of death or serious injury were received related to this case.However, the operator was exposed to analyzer liquid and blood and was decontaminated as per hospital policy and attended occupational health, where he was advised it was probably low risk.A blood sample and another sample will be taken in 6 months.The operator had no open wounds.

Manufacturer Narrative

No further information was available, and the device was discarded by the user.Hence, radiometer closed the investigation.

• Brand Name: ABL90 FLEX SP90
• Type of Device: ABL90 FLEX SOLUTION PACK
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• Manufacturer Contact: kristina toft ; aakandevej 21; broenshoej, 2720 ; DA 2720 ; 538273349
• MDR Report Key: 6356135
• MDR Text Key: 68284832
• Report Number: 3002807968-2017-00005
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: XV-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1