MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-28 for CWP 100 CENTRAL WATER TREATMENT SYSTEM 104 H manufactured by Mar Cor Purification.
[103774219]
A facility reported while a patient care technician was disconnecting the acid connections from the dialysis wall box used with their cwp 100 central water treatment system, the technician cut her hand on the dialysis chair after the connector fitting released. The technician did not need stitches and is reported to be doing fine. Mar cor regulatory affairs followed up with the facility's technical manager and he reported he has since trained the facility staff how to disconnect the connections from the wall boxes to avoid hitting their hands when the connection fitting releases. This complaint will continue being monitored in the mar cor purification complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[103774220]
A facility reported while a patient care technician was disconnecting the acid connections from the dialysis wall box used with their cwp 100 central water treatment system, the technician cut her hand on the dialysis chair after the connector fitting released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2018-00002 |
| MDR Report Key | 7380115 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2018-03-28 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14550 28TH AVE. N. |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE. N. |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CWP 100 CENTRAL WATER TREATMENT SYSTEM |
| Generic Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Product Code | FIP |
| Date Received | 2018-03-28 |
| Model Number | 104 H |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVE. N. PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-28 |