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U.S. Department of Health and Human Services

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

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HAEMONETICS CORPORATION SOFTWARE SOLUTIONS SURROUND LABORATORY MANAGEMENT SOFTWARE SURROUND¿ LABORATORY MANAGEMENT SOFTWARE Back to Search Results
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.

 
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Brand NameSURROUND LABORATORY MANAGEMENT SOFTWARE
Type of DeviceSURROUND¿ 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 Key7032986
MDR Text Key93130066
Report Number2951268-2017-00003
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberBK140199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 11/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSURROUND 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
Event Location No Information
Date Manufacturer Received10/19/2017
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

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