MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for ELDORADO DONOR 3.0.0 EDD3.0.0 manufactured by Haemonetics Corporation Software Solutions.
[58772609]
It was initially identified in the investigation that the prohibiting factors for 'lowvol' were not in place on the user table setup. The customer's initial mitigation after the issue was discovered was to add a prohibiting factor to the 'lowvol' failure codes so that any subsequent donations recorded with this failure code will allow the defined draw failure prohibiting factor to post to those failed donations. The investigation is not complete and no root cause of the issue has been identified. A supplemental report will be submitted upon conclusion of the investigation. Software issue, no device available.
Patient Sequence No: 1, Text Type: N, H10
[58772610]
The customer reported on (b)(6) 2016 that an untested donation rbc component was able to be labeled based on the donor record's historic blood type without the eldorado donor application requiring an override. The donor had been collected off-line (i. E. On a paper medical history form) and there was a problem with the donor's initial phlebotomy needle stick. The staff member entered the 'lowvol' draw failure code on the medical history form for that initial inadequate donation draw. Subsequently, a second phlebotomy stick was successful and a full donor unit was collected and the draw information was entered on the same paper medical history form that had been used for the initial needle sick. However, the initial stick's 'lowvol' draw failure code was not removed (in error) from. When the draw information for the successful second collection attempt was entered into the eldorado donor application, the data entry user entered the 'lowvol' draw failure code and met the successful full donor unit. The 'lowvol' failure code was not mapped in the user table setup to post a prohibiting factor nor was it defined to require unit testing or draw information. Because there was no prohibiting factor defined to post, and this failure code was defined to not require unit testing, there were no conditions associated to the component manufacture record to prevent the untested donation to be identified. This donor had a historical blood type on record and the application allowed the rbc component to be labeled based on the donor's historic blood type when no current test results had been received for that donation. The customer found the issue just prior to shipping this untested rbc component to their end user. The customer subsequently provided the information that of the original four cases, the initial case was caught and stopped at shipping. The other three cases all had components distributed and transfused, however the customer verified testing from donations prior to and following the problem units and all routine donor testing is acceptable. No adverse transfusion reactions were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2016-00001 |
| MDR Report Key | 6055315 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-09-26 |
| Date of Event | 2016-09-26 |
| Date Mfgr Received | 2016-09-26 |
| Device Manufacturer Date | 2015-08-25 |
| Date Added to Maude | 2016-10-25 |
| 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 | MS JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Manufacturer G1 | HAEMONETICS CORP |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELDORADO DONOR 3.0.0 |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2016-10-25 |
| Model Number | EDD3.0.0 |
| Operator | PHLEBOTOMIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-10-25 |