MAUDE Adverse Event Report: SENDX MEDICAL, INC. ABL80 SC80; ELECTRODE MEASUREMENT, BLOOD-GAS PH

Model Number SC80

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Customer stated that a sc80 sensor cassette on the abl80 flex analyzer failed and generated a low po2 value on a patient sample after the physician placed the patient on oxygen.The reported po2 value was approximately 270 mmgh.The physician questioned the result and reran the sample on the abl800 analyzer, which generated a po2 result of approximately 400mmhg.There was no reported injury, diagnosis or treatment based on the low po2 result.(b)(4).

Manufacturer Narrative

Evaluation of the failed sensor cassette is currently in progress.However, sendx medical did evaluate the data logs form the failed sensor cassette.It was discovered that the po2 parameter failed manual qc and the customer did not follow the manufacturer's recommendations for such failures (ie follow the analyzer instructions on the screen or the recommendations in the operator's manual).Instead, the customer ignored the failure and ran a patient sample.Incidentally, the analyzer generated a low po2 result on the patient sample.However, it should be noted that the analyzer performed according to specifications and notified the user that manual qc failed for po2, whereby the customer should not have run a patient sample on the sensor cassette without first resolving the manual qc failure.

• Brand Name: ABL80 SC80
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GAS PH
• Manufacturer (Section D): SENDX MEDICAL, INC.; 1945 palomar oaks way; carlsbad CA 92011
• Manufacturer Contact: jon brockman ; 1945 palomar oaks way; carlsbad, CA 92011 ; 7606033412
• MDR Report Key: 4098414
• MDR Text Key: 4764341
• Report Number: 2027541-2014-00002
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2014
• Device Model Number: SC80
• Device Catalogue Number: 945-671
• Device Lot Number: 205707
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR