MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-19 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[24670666]
A steris field service technician arrived onsite, inspected the unit, and identified a loose hose clamp on the hose which led to the pre-filter assembly. Furthermore the technician identified the user facility's water pressure was at 80 psi. The reliance eps's water pressure specification is 40 - 50 psi. The technician adjusted/lowered the user facility's water pressure level. He also installed a pressure regulator and hose clamps to the affected area as a precautionary measure to accommodate for any spikes in pressure levels. The unit subject of the reported event was installed on (b)(6) 2015 and is under steris warranty. Per the eps installation/start-up checklist, the equipment/utility requirements indicate the water pressure levels were within the acceptable range for use. It is unknown how the user facility's water pressure raised to above the acceptable range.
Patient Sequence No: 1, Text Type: N, H10
[24670667]
The user facility reported a hose on their reliance eps loosened and leaked water. No report of injury or procedural delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2015-00052 |
| MDR Report Key | 5014805 |
| Date Received | 2015-08-19 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-07-27 |
| Date Mfgr Received | 2015-07-27 |
| Date Added to Maude | 2015-08-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RELIANCE ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | RELIANCE EPS |
| Product Code | NZA |
| Date Received | 2015-08-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, QUEBEC GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-19 |