MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-26 for VISTA 923000320 manufactured by Terumo Bct.
[2843465]
The customer called to report that the operator had assigned a donor to a trima procedure but the person run on the procedure was not that donor. The total blood volume (tbv) that was calculated was therefore incorrect (in the unsafe direction, so the donor was run on a higher tbv than actual) for this donor and there is potential for overinfusion of anti-coagulant. This was a single platelet procedure, and the donor did not have a reaction during the procedure, nor did they present any issues afterward. The customer declined to provide the patient's age or weight. This report is being filed due to operator error that has the potential to cause or contribute to a death or injury if this same failure were to recur.
Patient Sequence No: 1, Text Type: D, B5
[10054075]
(b)(4). Investigation: a review of the product disposition form (pdf) system for this catalog number was performed and no production defect records were found. The customer wanted to know the order of operations of people who interacted with the vista (software for assigning donors) system. This was provided to them via audit trail utility in vista. Root cause: operator error. Corrective action: the customer is handling the documentation issues with the run records on their end.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2012-00526 |
| MDR Report Key | 2671683 |
| Report Source | 05 |
| Date Received | 2012-07-26 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-06-29 |
| Date Mfgr Received | 2012-06-29 |
| Date Added to Maude | 2012-11-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KRISTEN COHEN |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISTA |
| Generic Name | VISTA INFORMATION SYSTEM |
| Product Code | NYO |
| Date Received | 2012-07-26 |
| Model Number | 923000320 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-07-26 |