MAUDE Adverse Event Report: SENDX MEDICAL INC. ABL80 FLEX CO-OX ANALYZER; BLOOD- GASES ANALYZER

Model Number	393-841
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abnormal Blood Gases (1034)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A blood gas sample tested from a patient was low on the bicarb.He was then taken to the er and given bicarb as treatment.The patient was released and sent home with more bicarb to take.When the operator saw the blood gas results of the patient run on another analyzer, a difference in values was seen.The therapists went to the er to check on that patient to find out that the patient had already been released.They requested the patient to return for a repeat blood gas and marked the analyzer to not be used until it can be checked/repaired by a field service engineer.A field service visited the site to evaluate the analyzer.The engineer reviewed the analyzer logs and observed the ph and pco2 parameters had failed external quality checks (qc).Results from these parameters are used in the derivation of bicarb.Further review determined that the qc lockout feature was not active on this analyzer.The qc lockout feature would have disabled analysis on the ph and pco2 parameters in the event of a qc failure.The service engineer also observed corrosion on the sensor connector board.Corrective action: replaced sensor connector board due to observed corrosion.The engineer activated the qc lockout feature which will prevent blood analysis on parameters that experience external qc failure.The sensor cassette that experienced the external qc failures was replaced.Following replacement blood samples compared favorably with a comparison analyzer.The operator agreed those were acceptable results.

• Brand Name: ABL80 FLEX CO-OX ANALYZER
• Common Device Name: BLOOD- GASES ANALYZER
• Manufacturer (Section D): SENDX MEDICAL INC.; 1945 palmoar oaks way; carlsbad CA 92011
• MDR Report Key: 7159512
• Report Number: 2027541-2018-00001
• Device Sequence Number: 19305512
• Product Code: CGA
• UDI-Device Identifier: 05700693938417
• UDI-Public: (01)05700693938417
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K151639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: Occupational Therapist
• Device Model Number: 393-841
• Device Catalogue Number: 393-841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1