MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO VISION; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number 6904577

Device Problem Failure to Deliver (2338)

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

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6)2019 an ortho field engineer (fe) arrived at the customer site and discovered that the syringe was leaking.Fe replaced syringe, lubricated the cavro dilutor and calibrated the encoder.Fe performed pump test and confirmed pump test failure, replaced fawa pump successfully and repeated pump test with no errors.The fe reported that the instrument is still under validation and live testing has not started.Although service was successful in addressing the leaking syringe, the sample contamination due to the leak is still a concern.Dra (b)(4) is assigned to r&d to further investigate/mitigate the potential sample contamination.No incorrect or erroneous results were reported as a result of this incident.There was no risk present at the time of the incident.There was no harm to any patient as this incident occurred during validation testing of the instrument prior to use in patient testing.

Event Description

(b)(6) rep reports the discovery of the probe appearing to dispense mts diluent 2 back into the sample as it makes attempts to collect the packed cells for either dat testing or x-match testing.During validation testing of dat and x-match on the vision analyzer, it was observed that the probe is not dispensing cells into to cards.Instrument presenting (no cells) nc as flags.Visual inspection confirmed that no cells were dispensed.Ortho rep repeated both tests, using "packed cells" as required, but still getting "nc" codes.Claimed she noticed that the probe will dispense diluent first into test tubes before making the red cell suspension.Other tests are performing as expected.

• Brand Name: ORTHO VISION
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 8344998
• MDR Text Key: 139837251
• Report Number: 2250051-2019-00006
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1