MAUDE Adverse Event Report: RADIOMETER MEDICAL APS D513 DISPOSABLE WASTE CONTAINER

Model Number	905-802
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the customer could observe a pressurized waste container.The customer found the bottom left cover lifting off the abl800 flex analyzer because it was being propped up by a bulging waste bottle.The bottle lot number is ml54 manufactured on 14-01-2022.It was under so much pressure the bulging bottle was preventing the lid from being held down by the magnets and it kept falling off and would not stay on.The waste consists of blood and used qc and calibration liquid and if the waste container is inflated, there is a risk of waste squirting out of the container.
Additional Manufacturer Narrative
The following root causes have been identified: 1, incorrect guidecon assembly pressure caused the improper guidecon mounting.2, validation did not include the verification if the incorrect guidecon assembly pressure will trigger an alarm on machine.Testing has shown that if a waste container is inflated, there is no risk of waste squirting out of the container and thus no risk of serious injury.Radiometer risk management files have been updated accordingly and this incident is no longer considered reportable.

• Brand Name: D513 DISPOSABLE WASTE CONTAINER
• Common Device Name: D513 DISPOSABLE WASTE CONTAINER
• 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: 13974890
• Report Number: 3002807968-2022-00012
• Device Sequence Number: 6370555
• Product Code: CHL
• UDI-Device Identifier: 05700699058027
• UDI-Public: (01)05700699058027(17)270131(10)ML54
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: Health Professional
• Device Model Number: 905-802
• Device Catalogue Number: 905-802
• Device Lot Number: ML54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown