MAUDE Adverse Event Report: RADIOMETER MEDICAL APS S4980 RINSE SOLUTION

Model Number	944-132
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the customer could observe a pressurized waste container.When changing it, some of the contents escaped from the bottle entry port.The waste container in question was previously a s4980 rinse solution bottle.The s4980 rinse solution bottle is intended to be used as a waste container when the rinse solution is used up.The waste consists of blood and used qc and calibration liquid.
Additional Manufacturer Narrative
Production records and reference samples were checked and no nonconformities were observed.The defective product could not be checked as it was discarded by the customer.The contents of the waste bottle may be spilled if pressure is build-up inside the bottle and its not finding way to escape (blocked ventilation channel) while the bottle is filling.The complained bottle was previously used as a rinsing liquid, which excludes the possibility for ventilation channel to be blocked, because with a blocked channel it would be not possible to use this bottle.It is not possible to determine the root cause without the defective product, hence the root cause remains unknown.
Additional Manufacturer Narrative
Further investigation has shown that it actually is possible to use a rinse bottle with a blocked ventilation channel.

• Brand Name: S4980 RINSE SOLUTION
• Common Device Name: S4980 RINSE SOLUTION
• 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: 13384162
• Report Number: 3002807968-2022-00002
• Device Sequence Number: 5136239
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2150N007
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 05/12/2022

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: 944-132
• Device Catalogue Number: 944-132
• Device Lot Number: ME53
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 02/04/2022; 04/12/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/25/2022; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown