MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-24 for VISTA INFORMATION SYSTEM 923000320 manufactured by Terumo Bct.
[2817033]
The customer declined to provide the patient information.
Patient Sequence No: 1, Text Type: D, B5
[10072780]
(b)(4). This report is being filed to provide additional information. Investigation: the procedure was aborted right after prime due to an infiltration and no blood was drawn from the donor. The donor did not have a reaction during the procedure, nor did they present any issues afterward and no medical intervention was performed. This is a software product which does not have an associated technical file, simply a batch work order which would document any production defects. A review of the product disposition file system for this catalog number was performed and no records were found. Root cause: operator error. The customer's sales person, was notified so that he could follow up with the customer and possibly consider some re-training for the operators.
Patient Sequence No: 1, Text Type: N, H10
[19573676]
(b)(4). Investigation evaluation and corrective actions are in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[19843032]
A customer reported that a donor was assigned to a machine, but then a different donor was run on that machine using the original donor's info. The donor who was actually drawn on the machine had a smaller tbv than the original donor, but the run was aborted immediately after prime. There was no donor reaction and no blood was drawn successfully from the donor. Patient information is unavailable at this time. This report is being filed due to an operator error that would likely cause or contribute to a death or injury if this same failure were to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2012-00381 |
| MDR Report Key | 2626923 |
| Report Source | 05 |
| Date Received | 2012-06-24 |
| Date of Report | 2012-05-29 |
| Date of Event | 2012-05-29 |
| Date Mfgr Received | 2012-07-20 |
| Device Manufacturer Date | 2010-04-28 |
| Date Added to Maude | 2012-10-16 |
| 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 | MR. MATTHEW BICKFORD |
| Manufacturer Street | 10811 W. COLLINS AVE. |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISTA INFORMATION SYSTEM |
| Generic Name | VISTA INFORMATION SYSTEM |
| Product Code | NYO |
| Date Received | 2012-06-24 |
| Model Number | 923000320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-06-24 |