MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000 SUBSYSTEM, WATER PURIFICATION

Model Number AQUABPLUS 2000

Device Problems Melted (1385); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Date returned to manufacturer added. The protection switch from the reverse osmosis (ro) machine was returned to the manufacturer for physical evaluation. A visual examination was performed on the switch. The switch was disassembled and a deformity of the plastic rocker was observed. The deformation caused an incomplete closure of the electrical contact from one of the three line conductors. An electrical test was performed on the device which confirmed that one line was not activated. The manufacturer found the machine to have been conforming to specification. Based on concentrate pressure evaluation at the manufacturing site during final release and information regarding the customer site connection, the manufacturer concluded that the electrical connection at the power supply was incorrect performed at the customer site. The manufacturer states that the device was functioning at the customer site without reaching the intended concentrate pressure; however, the electrical phase connection would be hardly detectable and perhaps not suspected. There would be a final high current at one of the phases, which would be generating the overheating leading to the deformation of the switch component. As a consequence of the air gap of the electrical contact, the motor would only operator with two line conductors and trip the motor protection switch, which would lead to customer observance of the issue. The motor protection switch was replaced on the ro unit at the customer site and the rotation direction was corrected. There is no indication of any systemic design, material, or manufacturing related issue. The investigation into the cause of the complaint was able to confirm the reported event. The visual examination and electrical testing of the protection switch confirmed that the part sustained heat damage. Therefore, the complaint is confirmed.

Manufacturer Narrative

A plant investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

An installation logistics manager for vivonics reported that an aquabplus reverse osmosis machine underwent troubleshooting for a power failure. During machine repair, the manager had discovered that the power-switch terminal connections were melted. There was no report of heat damage to the machine¿s other components. The area technical operations manager did report evidence of arching. The power-switch is being returned to the manufacturer for physical evaluation. No further information has been made available at this time.

• Brand Name: AQUABPLUS 2000
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer (Section G): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7139551
• MDR Text Key: 254790953
• Report Number: 3010850471-2017-00003
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AQUABPLUS 2000
• Device Catalogue Number: G02040107-US
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse