MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90; ABL90 FLEX PLUS

Catalog Number 393-092

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Shock (2072); Distress (2329)

Event Date 08/07/2016

Event Type  No Answer Provided  

Event Description

According to the complaint, on (b)(6) 2016 a health care assistant, who is very experienced and competent, and had been trained to use the abl90 flex, was asked to run a sample of blood in a 2.5ml sampling syringe.She tried this in the usual way, but the machine did not seem to take any blood.So she wondered if she had run it incorrectly, and thought perhaps she should have used a clotcatcher.She then tried to run the sample again, this time with a clotcatcher on the syringe.Suddenly she found herself sprayed with blood - over her uniform, on her face and in her hair.A colleague then took the syringe and ran the sample, whilst she went to clean herself up and change.It was reported, that there was a considerable spattering of blood there, not a couple of drops.No medical treatment was required.The affected person was somewhat shocked and distressed, but not physically injured.Blood went into her ear, but fortunately not into her mouth.According to the customer, the user made an error, and anyone used to injecting blood into an analyzer might do the same, if they weren't concentrating.The customer has suggested that they will emphasise this poin in future training.

Manufacturer Narrative

The investigation showed that the customer was using the clot catcher device in a way it is not intended for.

• Brand Name: ABL90
• Type of Device: ABL90 FLEX PLUS
• 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: 5938765
• MDR Text Key: 54277521
• Report Number: 3002807968-2016-00033
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other