MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for BIOPURE HX2 3029712 manufactured by Mar Cor Purification.
[30629959]
Mar cor was notified of a fire within the hx2 control panel on (b)(6) 2015. Manufacturer of the electrical panel's preliminary investigation show a fuse in the fuse block failed to completely open. The root cause is currently under investigation. This failure occurred within a fully enclosed electrical panel. The panel and ro system meet safety requirements and have been tested per ansi/ul 61010-1. This failure presents no risk to patients or the user. Mar cor will continue to monitor this complaint within the complaint system.
Patient Sequence No: 1, Text Type: N, H10
[30629960]
Biopure hx2 ro system control had a fire inside the electrical cabinet. This happened over a weekend with no patients or operators affected. Hx2 was evaluated and repaired.
Patient Sequence No: 1, Text Type: D, B5
[39787165]
Follow up to 3019131-2015-00005. The phase b fuse failed, leading to the breakdown/electrical fire in the heater controller fuse holder. The 180ohm of residual resistance between the poles of the phase b fuse holder suggest the fuse turned into a 436w heater element at the time of failure. This would provide enough energy to create the damage seen. A current limiting / timing delay fuse has a higher heat capacity that a fast acting fuse. (b)(4) believes that the combination of three factors (power brown outs, pulsing load and thermal isolation) allowed the fuse in question to be repeatedly heated and cooled. This temperature cycling caused the fuse to partially melt internally, creating a 180 ohm bridge measured. This bridging turned the fuse into a heater. With no way to...
Patient Sequence No: 1, Text Type: N, H10
[39787166]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2015-00005 |
| MDR Report Key | 5199139 |
| Date Received | 2015-11-03 |
| Date of Report | 2016-03-04 |
| Date of Event | 2015-10-04 |
| Date Mfgr Received | 2015-10-05 |
| Device Manufacturer Date | 2015-01-20 |
| Date Added to Maude | 2015-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS 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 | BIOPURE HX2 |
| Generic Name | REVERSE OSMOSIS WATER TREATMENT SYSTEM |
| Product Code | FIP |
| Date Received | 2015-11-03 |
| Model Number | 3029712 |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Brand Name | BIOPURE HX2 |
| Generic Name | REVERSE OSMOSIS WATER TREATMENT SYSTEM, PRODUCT CODE: FIP |
| Product Code | FIP |
| Date Received | 2015-11-03 |
| Model Number | 3029712 |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-03 |