MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-10-27 for VISTA SOFTWARE 000000000923000327 manufactured by Terumo Bct.
[18091218]
The customer requested an investigation into the reason a donor was eligible for donation in vista when the donor had both a previous non-rinseback procedure and a whole blood donation. Customer is concerned that vista did not defer the donor appropriately per the non-rinseback rule in vista. No medical intervention was required for this event. Donor has been deferred for 112 days from the date of last donation. This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for death or injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[18534752]
Investigation: per the customer's records, the donor had an apheresis donation without rinseback on (b)(6) 2014, a whole blood donation on (b)(6) 2014, and an apheresis donation with rinseback on (b)(6) 2014. She was then permitted by vista to donate on 07/23/2014. The donor's accumulated red blood cell loss is 419 ml in this time period of 34 days. Per the vista admin manual, the vista non-rinseback rule looks for 'events' in 8 weeks preceding anon-rinseback procedure, it does not look for 'events' subsequent to a non-rinseback procedure. The donor had a non-rinseback and then gave whole blood, then one platelet donation with rinseback, then one platelet donation without rinseback on (b)(6) 2014. The donor would now be deferred in vista as the whole blood donation was preceding the last non- rinseback procedure. Customer determined that the whole blood donation ((b)(6) 2014) import was completed 1 day after the apheresis donation on (b)(6) 2014 as they have a weekly import of blood loss from the blood bank system into vista on sundays. Investigation is in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[25384370]
Investigation: a review of the last year of service history for this software at this account indicated no other reports related to this issue. No additional complaints have been received for this device regarding the reported condition. Terumo bct's software specialist reviewed the standard operating protocol/procedure (sop)from the customer's site. Terumo bct's software specialist determined that the customer's sopis more conservative than the regulation and that it does not 'match up' with the vista system's no rinseback procedure rule, with the regard to a single no rinseback procedure rbc loss total. Root cause: the vista software operated as intended. The customer's sop regarding donor deferrals and vista are not matched up.
Patient Sequence No: 1, Text Type: N, H10
[50822395]
This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2014-00430 |
| MDR Report Key | 4202318 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-10-27 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2016-07-28 |
| Device Manufacturer Date | 2012-07-25 |
| Date Added to Maude | 2014-10-27 |
| 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 | ROBBIN CRAFE |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392282 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISTA SOFTWARE |
| Generic Name | VISTA 3.2 WITH SERVICE PACK 3 |
| Product Code | MMH |
| Date Received | 2014-10-27 |
| Model Number | 000000000923000327 |
| Lot Number | 07U5087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-27 |