MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-20 for VISTA 923000320 manufactured by Terumo Bct.
[20231299]
The customer reported a potential anticoagulant (ac) overinfusion due to incorrectly entered donor information. The procedure was discontinued at 25 minutes and rinseback was performed. The donor did not experience any adverse effects due to the incident. This report is being filed due to device malfunction (in the form of operator error) that has the potential to cause or contribute to a death or injury.
Patient Sequence No: 1, Text Type: D, B5
[20601152]
(b)(4). Investigation: it was confirmed with the clinic that the procedure was discontinued at approximately 25min. With minimal product collected and rinseback was performed. The donor had no adverse experiences. This is a software product which does not have an associated technical file, simply a batch work order which would document any production defects. None were found. Root cause: operator error. Corrective action: (b)(4). Operator error, no evaluation necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2012-00879 |
| MDR Report Key | 2840598 |
| Report Source | 05 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-10-24 |
| Date Mfgr Received | 2012-10-25 |
| Device Manufacturer Date | 2010-06-24 |
| Date Added to Maude | 2013-02-26 |
| 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 | 2012-11-20 |
| Model Number | 923000320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-11-20 |