MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS SURROUND LABORATORY MANAGEMENT SOFTWARE; SURROUND¿ LABORATORY MANAGEMENT SOFTWARE

Model Number SURROUND V4.1 - 5.0.2

Device Problem Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Surround test results arrive in an ortho.Dat file from the instrument.This file contains results for multiple tests with each group (or plate) of results separated in the file by header lines that specify the test.The surround ortho summit filter program grabs this file, and then recreates the file with the same ortho.Dat name in order to remove blank lines from the file.It then separates it into batch files based on the header received from the instrument and renames each file with ortho.Dat, with each file containing samples and results for only 1 test.The resulting files are then parsed into the database via run file collector process.Ortho recommended to use a different naming convention for the file to reduce the risk of data being overwritten if two tests are ran at the same time stamp.Further investigation with development and technical services showed that ortho filter was processing the ortho.Dat file, when a batch containing hbc results started coming in.Two files fused together into a single file and hbc header got overwritten.Ortho filter job is configured to run once per minute.(b)(6) informed that the user did not wait 1 min between the transfers as they usually do.This design issue has been addressed and corrected in the latest release of the application, surround version 5.1.

Event Description

On (b)(6) 2017, (b)(6) informed haemonetics that a single unit was tested (b)(6) on ortho summit instrument for (b)(6), but received (b)(6) result in surround.Internal investigation determined that surround received a run file with (b)(6) test result from the instrument.There were (b)(4) samples in the batch.Ortho support performed the investigation and informed that hcv0350 plate had (b)(4) units.The remaining 45 units were part of hbc batch, which should have come in a different file.On october 26, 2017, (b)(6) notified that all ortho batches received in the surround file were manually reviewed and only one unit had a discrepant result.The customer has an internal manual process to put all samples on hold as soon as they are tested initially (b)(6).(b)(6) qa will follow internal incident management process to document this issue, but will not be reporting it to fda since the unit did not leave the facility.Haemonetics has determined that this issue is present in surround version 4.1 through 5.0.2.Haemonetics has determined that the primary hazard for this software malfunction is an elevated risk that an unsuitable blood/plasma product is made available for the next step in the manufacturing process.An unsuitable product may have an elevated risk for the patient to receive a transfusion transmissible infection.

• Brand Name: SURROUND LABORATORY MANAGEMENT SOFTWARE
• Type of Device: SURROUND¿ LABORATORY MANAGEMENT SOFTWARE
• Manufacturer (Section D): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184
• MDR Report Key: 7032986
• MDR Text Key: 93130066
• Report Number: 2951268-2017-00003
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURROUND V4.1 - 5.0.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1