MAUDE Adverse Event Report: MAR COR PURIFICATION BIOPURE HX2; REVERSE OSMOSIS WATER TREATMENT SYSTEM

Model Number 3029712

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

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

• Brand Name: BIOPURE HX2
• Type of Device: REVERSE OSMOSIS WATER TREATMENT SYSTEM
• 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 Key: 5199139
• MDR Text Key: 30629959
• Report Number: 3019131-2015-00005
• Device Sequence Number: 0
• Product Code: FIP
• Reporter Country Code: US
• PMA/PMN Number: K133149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 3029712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1