MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number 393-090

Device Problems Output Problem (3005); Missing Test Results (3267)

Patient Problem Dyspnea (1816)

Event Date 10/21/2021

Event Type  Injury  

Event Description

According to the complaint, on (b)(6) 2021 the abl90 flex reported a result for lactic acid which was normal, and the patient was thus not treated.On (b)(6) 2021, the patient was found to be in worse condition, dyspnea, and cyanosis of the whole-body skin.Endotracheal intubation was given.Blood gas analysis was carried out again.It was found that the lactic acid value was not displayed.The maintenance personnel found that the sensor cassette had quality problems.Due to these problems, abnormal blood gas analysis results were reported, which failed to guide the patient to use drugs in time, resulting in aggravation of the patient's condition.The patient was requiring rescue and the use of respirator.

Manufacturer Narrative

Investigation confirms that the sensor cassette failed after 13 days in use with error 1310 responce error during calibration failure.A change of sensor cassette most likely resolved the issue.

Manufacturer Narrative

Investigation has shown that all patient results provided on the days of the reported event 20th and 21st october 2021 have been marked with question mark and error code "210-calibration error present".As the results are question marked and calibration errors are present, the results should be evaluated before being used for clinical decisions as described in the instructions for use.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12906983
• MDR Text Key: 281508626
• Report Number: 3002807968-2021-00062
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0676N009
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention