MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-17 for CWP CWP 104H manufactured by Mar Cor Purification.
[21168346]
The case states that the customer notified mar cor of positive minncare (used to sanitize the ro water system) results in the ro water room reading. All wall boxes (point of use) and other locations were reading negative for minncare. This caused a delay in patient treatments. The source of the issue was a chemical hose not properly secured during servicing of the machine. This allowed minncare to leak into the bottom tray of the ro unit. Lack of proper airflow in the water room contributed to a false positive test strip indication (from vapor) of ro room water. Additional water sample testing showed the ro water room and all point of use locations negative for minncare. Auxiliary ro system was utilized during the investigation. Approximately 40 patients were delayed treatment for 4 hours. No patient illness or injury resulted from this incident. This complaint will continue to be maintained within mar cor purification complaint system.
Patient Sequence No: 1, Text Type: N, H10
[21238255]
Customer notified mar cor of positive minncare (used to sanitize the ro water system) results in the ro water room reading. All wall boxes (point of use) and other locations were reading negative for minncare. This caused a delay in patient treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2014-00025 |
| MDR Report Key | 4096955 |
| Report Source | 05 |
| Date Received | 2014-09-17 |
| Date of Report | 2014-09-12 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-09-29 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CWP |
| Generic Name | REVERSE OSMOSIS MACHINE |
| Product Code | FIP |
| Date Received | 2014-09-17 |
| Model Number | CWP 104H |
| 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 MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-17 |