MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 <6> SYSTEM; BLOOD GAS ANALYZER

Catalog Number	03337154001
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of corroded parts on a cobas b221 instrument.Pictures were provided indicating some parts were melted.The reporter stated leakage was visible near a tubing connector associated with 2 cartridges of the instrument.There were green deposits on the connectors of the metabolite-sensitive sensor (mss) measuring chamber and the cable actuator.The mainboard unit, the co-oximetry (coox) cuvette unit and the actuator board showed signs of melting.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Based on the information provided, the investigation determined a leak in a cartridge and cuvette holder caused liquid to enter the b221 instrument which damaged the electronic parts causing short circuits and corrosion.The affected parts were not sent for further investigation.The customer confirmed that the instrument was working fine after replacing the affected parts.The specific root cause for the leak in the cartridge could not be determined.This particular b221 instrument passed all quality checks and met specifications prior to release.As the instrument worked properly prior to release, the investigation determined the event was consistent with the cartridge being damaged during transport.

• Brand Name: COBAS B 221 <6> SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17323522
• Report Number: 1823260-2023-02249
• Device Sequence Number: 12146627
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032311
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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 Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 07/21/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown