MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-14 for 120 RELIANCE CART WASHER manufactured by Steris Canada Corporation.
[3244869]
The user facility reported that their 120l cart washer was leaking water. The amount of water was estimated to be several gallons. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[10287746]
A steris service technician inspected the washer and found that welds on the recirculation pump had separated. The technician noted that "debris" was found in the chamber filters. The separation of the welds on the recirculation pump can be attributed to the "debris" getting into the recirculation pump and over time allowing wear on the pump subsequently allowing the recirculation pump to separate. The cleaning of the chamber filter is the user facility's responsibility and is to be completed daily as instructed in the operator manual. The operator manual states (pp. 6-3), "daily- after last cycle of the day, allow machine to cool and then remove and clean large filter in bottom of chamber". The technician advised the user facility the importance of the chamber filters being cleaned daily. The technician repaired the unit, ran a test cycle and confirmed the unit was operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00121 |
| MDR Report Key | 2873933 |
| Report Source | 06 |
| Date Received | 2012-12-14 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-11-15 |
| Date Mfgr Received | 2012-11-15 |
| Date Added to Maude | 2013-03-20 |
| 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 | 120 RELIANCE CART WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2012-12-14 |
| 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 GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-14 |