MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2500 SUBSYSTEM, WATER PURIFICATION

Model Number AQUABPLUS 2500

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6), an installation logistics manager for vivonics, reported that an aquabplus 2500 reverse osmosis machine, located at a user facility, was removed from service due to a t1 test failure that occurred during set-up for hemodialysis (hd) use. It was reported to henry, by the user facility biomedical technician (biomed), that the sd card was burnt and there was an issue with the motherboard. This information was reported to fmcna rtg on (b)(6) 2018 during a conference call. The hd patients at this facility were able to receive treatment at another facility until the unit was repaired. There was no harm to any patients or individuals due to this event. There was no report of heat damage to the machine¿s other components. The biomed replaced the sd card and motherboard to resolve the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. The sd card was stated to be available to be returned to vivonic for physical evaluation.

• Brand Name: AQUABPLUS 2500
• 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: 7234041
• MDR Text Key: 98984541
• Report Number: 3010850471-2018-00001
• 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: 07/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AQUABPLUS 2500
• Device Catalogue Number: G02040108-US
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 06/29/2018
• 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