MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX; BLOOD GAS ANALYZER

Model Number ABL90 FLEX

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Low Test Results (2458)

Patient Problem Discomfort (2330)

Event Date 12/13/2014

Event Type  malfunction  

Event Description

The incident involved two abl90 flex analyzers, which were installed on (b)(6) 2013.They were meant to replace the old abl 825 analyzers.However, on the abl90 po2 results were low and so2 results slightly higher compared to when the same samples were measured on the abl825.The po2 results were typically 20 mmhg below the results from the abl 825 and the results were inconsistent with the pt's condition.As a consequence one pt was placed on home oxygen as a precaution.Because of this, the abl90 analyzers were taken out of operation and the old abl825 analyzers were used in stead.

Manufacturer Narrative

Data-logs from the analyzers have been investigated.In one of the analyzers it could be detected that a small air bubble had been in the in the fluid pathway.In the other analyzer nothing abnormal was found.According to the customer, the solution packs have been frozen during transport and this could be a possible cause.The service engineer replaced the inlet on both analyzers, and after that they have performed as expected.The inlets, which was replaced, was of an old type and according to the service engineer, they were defective.As, changing the inlets solved the problem, the most likely root cause is the defective inlets.The frozen solution packs may have contributed to the problem.

• Brand Name: ABL90 FLEX
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj ; 8273827
• MDR Report Key: 3727073
• MDR Text Key: 4326532
• Report Number: 3002807968-2014-00008
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2014

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 Model Number: ABL90 FLEX
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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