MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-10 for RELIANCE 120 CART WASHER manufactured by Steris Canada Corporation.
[3305233]
The user facility reported that water was leaking from their reliance series 120 washer. The leak was contained by hospital staff and cleaned up using a wet vac. No procedural delays/cancellations have been reported. No injuries to the hospital staff or patients reported.
Patient Sequence No: 1, Text Type: D, B5
[10396240]
On (b)(4) 2012, routine preventative maintenance was performed on the device. The steris service technician reported there was an internal leak at the circulation pump. As the service technician's investigation could not be completed at the time of pm, the unit was taken out of service while investigating the root cause of the leak. During this period, unbeknownst to steris, the user returned the unit to service, at which time the reported event occurred. On (b)(6) 2012, the steris technician arrived on site and found water leaking from the unit. The technician inspected the unit and found the leak to be coming from the circulation pump and piping of the unit. The technician replaced the pump hose and seals on the unit. A test cycle was run and the unit was found to be operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00002 |
| MDR Report Key | 2907947 |
| Report Source | 06 |
| Date Received | 2013-01-10 |
| Date of Report | 2013-01-10 |
| Date of Event | 2012-12-13 |
| Date Mfgr Received | 2012-12-13 |
| Date Added to Maude | 2013-04-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE 120 CART WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2013-01-10 |
| Operator | OTHER HEALTH CARE 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 GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-10 |