MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-15 for APTIO AUTOMATION AP2 manufactured by Inpeco Sa.
[145124306]
The investigation and the analysis of the root cause have been completed by product distributor fse. The fse found that the cause of the sirius board burning was due to a wrong connection of the cable with part number 475283020 conducting 24v. The issue was a single event likely due to a manufacturing problem. No other occurrence was reported from the field. Since the event occurred during the automation system installation phase, there were no patient samples involved. The fse, who is a trained person on the use of the system, was on site and was working on the impacted module. All the electrical components included in the automation system, are tested for flame retardancy and they have a flammability rating at least v-2: in case of fire the electric parts are auto extinguishing in 10-30 seconds without any intervention of service and laboratory personnel. The fse replaced the atr sirius board using the correct cable connection. There was no injury associated to the event neither for the laboratory personnel nor for the fse. After the replacement and the reprogramming of the electrical board, the atr is working as expected and no similar event has been reported from the field. As immediate action, the fse replaced the damaged components. No preventive action is required according to investigation findings. There is no need to conduct a field safety corrective action since the event was a single occurrence and, as confirmed by the product distributor also, the event was not due to a design issue, so it has been evaluated not necessary to implement a design change.
Patient Sequence No: 1, Text Type: N, H10
[145124307]
The product distributor has notified inpeco that, during the installation phase of the automation system, smoke and burning smell were coming from the sirius board (electronic board) of the active track return (atr). Atr is a device that allows the carrier to return to the main lane of the track from the secondary lane, avoiding collision with carriers coming form the main lane. The board was found burned and it was replaced by the product distributor service personnel (fse).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2019-00005 |
| MDR Report Key | 8612226 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-15 |
| 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 | MRS EVA BALZAROTTI |
| Manufacturer Street | VIA TORRACCIA 26 |
| Manufacturer City | NOVAZZANO, 6883 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6883 |
| Manufacturer G1 | INPECO SPA |
| Manufacturer Street | VIA GIVOLETTO 15 |
| Manufacturer City | VAL DELLA TORRE, 10040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 10040 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIO AUTOMATION |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2019-05-15 |
| Model Number | AP2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INPECO SA |
| Manufacturer Address | VIA TORRACCIA, 26 NOVAZZANO, 6883 SZ 6883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |