MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-26 for 4400 SERIES RO SYSTEM 4400M manufactured by Biolab Equipment Ltd.
[15811149]
The case states that a 4400 reverse osmosis water system membrane clamp split. This caused a delay in patient dialysis.
Patient Sequence No: 1, Text Type: D, B5
[16212805]
Membrane housing clamp split on a 4400m ro system. This caused a water leak which lead to a delay in patient dialysis treatment. Approximately 40 patients were delayed treatment for 2 hours. No patients were injured as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710313-2014-00001 |
| MDR Report Key | 4038230 |
| Report Source | 06 |
| Date Received | 2014-08-26 |
| Date of Report | 2014-08-26 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-07-28 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2014-09-10 |
| 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 | 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 | BIOLAB EQUIPMENT LTD |
| Manufacturer Street | 3250 HARVESTER RD UNIT 6 |
| Manufacturer City | BURLINGTON, L7N3W9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L7N3W9 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4400 SERIES RO SYSTEM |
| Generic Name | REVERSE OSMOSIS MACHINE |
| Product Code | FIP |
| Date Received | 2014-08-26 |
| Model Number | 4400M |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOLAB EQUIPMENT LTD |
| Manufacturer Address | 3250 HARVESTER RD UNIT 6 BURLINGTON, L7N3W9 CA L7N3W9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-26 |