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

Catalog Number G02040107-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation. Review of the complaint history revealed that the reported event is a known problem. The reported event was confirmed based on a photo that was provided of the power supply cable. Most likely, the issue was caused by an electrical connection issue (which could lead to a power outage in the worst-case scenario). Review of the instructions for use (ifu) was not required because the issue was not user related. However, a review of the service manual was performed. This review revealed that part of the technical safety check consists of visually inspecting the aquabplus before use. A device history record (dhr) review was also performed. The device was found to be conforming to the specifications for an aquabplus, and was confirmed to be released without any discrepancies. Review of the repair history was not required. Since the reported issue is a known problem, reproduction of the failure was not required. Based on the provided photo, the reported problem was able to be confirmed. The issue was resolved onsite by replacing the 24v power supply cable.

Event Description

A user facility biomedical technician (bmt) reported finding discoloration on the connector of a 24-volt power supply cable from an aquabplus 2000 system. The connector was described as brownish looking. Upon further follow-up, it was reported that the discoloration was caused by overheating. It was suspected that there was a "high voltage spike in the area. To resolve the reported issue, the cable was replaced. The sample was not available to be returned for physical evaluation. A photo of the cable was provided for review. There was no reported patient involvement associated with the event.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11260465
• MDR Text Key: 229686928
• Report Number: 3010850471-2021-00004
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse