MAUDE Adverse Event Report: SENDX MEDICAL, INC. ABL80 FLEX ANALYZER; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number 393-839

Device Problems Contamination (1120); Fracture (1260); Contamination of Device Ingredient or Reagent (2901)

Patient Problem Abnormal Blood Gases (1034)

Event Date 09/10/2018

Event Type  Injury  

Event Description

A patient analysis was performed on the subject analyzer, abl80 flex serial number (b)(4), and based on the reported hct/thb result the patient received a blood transfusion.The user was suspicious of the subject analyzer's result and therefore performed another measurement on a comparison abl80 flex that was on-site.Measured results: subject analyzer: thb = 7.1g/dl hct = 22%.Comparison analyzer: thb = 13.7 g/dl hct = 42%.Based on a comparison of the results between the subject and comparison analyzers, the user concluded that the subject analyzer results were incorrect and the blood transfusion was unnecessary.A service technician evaluated the analyzer and found that the roller wheel assembly was not working properly.Further investigation revealed the roller wheel assembly housing was cracked around a set screw that is used to secure the roller wheel assembly to the roller motor shaft.The cracked housing resulted in roller wheel assembly slippage affecting sample aspiration and flushing.The issue was resolved following replacement of the roller wheel assembly.

Event Description

A patient analysis was performed on the subject analyzer, abl80 flex serial number (b)(4)., and based on the reported hct/thb result the patient received a blood transfusion.The user was suspicious of the subject analyzer's result and therefore performed another measurement on a comparison abl80 flex that was on-site.Measured results: subject analyzer: thb = 7.1g/dl hct = 22%.Comparison analyzer: thb = 13.7 g/dl hct = 42%.Based on a comparison of the results between the subject and comparison analyzers, the user concluded that the subject analyzer results were incorrect and the blood transfusion was unnecessary.A service technician evaluated the analyzer and found that the roller wheel assembly was not working properly.Further investigation revealed the roller wheel assembly housing was cracked around a set screw that is used to secure the roller wheel assembly to the roller motor shaft.The cracked housing resulted in roller wheel assembly slippage affecting sample aspiration and flushing.The issue was resolved following replacement of the roller wheel assembly.Update on 04/30/19.Device history record (dhr) for abl80 with serial number (b)(4) was reviewed.The review did not reveal any discrepancies or failures.Dhr sensor cassette sc80 with serial number (b)(4) was reviewed.There were no reworks or non-conformance associated with this sensor cassette.Both dhrs indicated that the products met all of the required specifications.The date of the incident is 09/10/18 @13:58.The roller wheel was replaced by an field service engineer on 09/27/18.The analyzer logs contain records from 04/28/18 to the rolloe wheel replacedment date of 09/27/18 was reviewed.The calibration logs do not show evidence calibration errors that would be consistent with a malfunctioning roller wheel.The analyzer's manual quality control (mqc) logs reveal that the end-user does not perform routine quality control with radiometer qc material as recommened.The end-user did perform qc on 09/11/18 ( the day following the incident) and the hct results were within performance speciifcations.The analyzer logs do not show clear evidence that the crach in the roller wheel affected analyzer performance leading up to and following the incident date.Since ethe roller wheel could not be returned for confirmation testing, this investigation into the roller wheel will conclude as "unable to confirm" with high confidence that the roller wheel did not contribute to the reported (-) hct bias.

• Brand Name: ABL80 FLEX ANALYZER
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): SENDX MEDICAL, INC.; 1945 palmoar oaks way; carlsbad CA 92011
• MDR Report Key: 7914865
• MDR Text Key: 121914791
• Report Number: 2027541-2018-00002
• Device Sequence Number: 1
• Product Code: JPI
• UDI-Device Identifier: 05700693938394
• UDI-Public: (01)05700693938394
• Combination Product (y/n): N
• PMA/PMN Number: K051804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-839
• Device Catalogue Number: 393-839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other