MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-11-15 for SURROUND? LABORATORY MANAGEMENT SOFTWARE SURROUND V4.1 - 5.0.2 manufactured by Haemonetics Corporation Software Solutions.
[93130066]
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
Patient Sequence No: 1, Text Type: N, H10
[93130068]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2017-00003 |
| MDR Report Key | 7032986 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-10-19 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-11-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID RAMSAY |
| Manufacturer Street | 400 WOOD ROAD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer G1 | HAEMONETICS CORP |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURROUND? LABORATORY MANAGEMENT SOFTWARE |
| Generic Name | SURROUND? LABORATORY MANAGEMENT SOFTWARE |
| Product Code | MMH |
| Date Received | 2017-11-15 |
| Model Number | SURROUND V4.1 - 5.0.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION SOFTWARE SOLUTIONS |
| Manufacturer Address | 4925 ROBERT J. MATTHEWS PARKWA SUITE 100 EL DORADO HILLS CA 95762 US 95762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |