MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for ELUTRA 70800 manufactured by Terumo Bct.
[54463134]
(b)(4). Investigation: the customer set up a new (unexpired) kit and continued with the procedure without incident. The elutra operator's manual directs the operator to check the expiration date on the disposable tubing set package, before loading the tubing set. No patient was involved and the product was not used. Terumo bct followed-up with thecustomer regarding the use of the expired set. The customer confirmed that no product was collected. The customer also said he checked his inventory for any other remaining unused expired kits to be discarded. The device history record (dhr) was reviewed for this lot. There were no issues noted in the dhr for this lot. Root cause: root cause was determined to be a user error in which the customer initially attempted to use an expired set.
Patient Sequence No: 1, Text Type: N, H10
[54463135]
The customer reported that they received an alarm during a setup for an elutra procedure. While the operator was troubleshooting, he noticed the elutra set expired in june2015. The expired set was discarded and a new elutra set was setup for the procedure. This is a laboratory device. No patient was connected at the time of the event. No patient information is reasonably known. The elutra collection set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2016-00494 |
| MDR Report Key | 5923339 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-08-09 |
| Device Manufacturer Date | 2014-07-15 |
| Date Added to Maude | 2016-09-01 |
| 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 | MATTHEW BICKFORD |
| Manufacturer Street | 10810 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 | 0 |
| Brand Name | ELUTRA |
| Generic Name | ELUTRA SET |
| Product Code | KSS |
| Date Received | 2016-09-01 |
| Catalog Number | 70800 |
| Lot Number | 07W15290 |
| Device Expiration Date | 2016-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-09-01 |