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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION BIOPURE HX2 REVERSE OSMOSIS WATER TREATMENT SYSTEM, PRODUCT CODE: FIP

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MAR COR PURIFICATION BIOPURE HX2 REVERSE OSMOSIS WATER TREATMENT SYSTEM, PRODUCT CODE: FIP Back to Search Results
Model Number 3029712
Device Problem Electrical /Electronic Property Problem
Event Date 10/04/2015
Event Type  Malfunction  
Manufacturer Narrative

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.

 
Event Description

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.

 
Manufacturer Narrative

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.

 
Event Description

 
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Brand NameBIOPURE HX2
Type of DeviceREVERSE OSMOSIS WATER TREATMENT SYSTEM, PRODUCT CODE: FIP
Manufacturer (Section D)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer (Section G)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer Contact
megan dickey
14550 28th avenue north
minneapolis , MN 55447
7635533300
MDR Report Key5199139
Report Number3019131-2015-00005
Device Sequence Number1
Product CodeFIP
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Repair
Type of Report Initial,Followup
Report Date 03/04/2016
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received11/03/2015
Is This A Product Problem Report? Yes
Device Operator BIOMEDICAL ENGINEER
Device MODEL Number3029712
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/20/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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