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

Catalog Number G02040108-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation. The review of the complaint history revealed that the reported event is a known problem. The reported event can be confirmed by means of the provided photo. Although machine files were requested for review, the sd card from the system was found to be corrupted. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. Based on the provided photo, the reported problem was able to be confirmed.

Event Description

A user facility's biomedical technician (biomed) reported that an aquabplus 2500 system had a motor protection switch failure. Patient treatments were interrupted for twenty minutes due to the failure. The machine was put in emergency mode and treatments were resumed. The machine ran in emergency mode for two days to allow patient treatments to continue. There were no indications of any adverse events, or patient injuries requiring medical intervention. After the motor protection switch was replaced, the system was returned to regular mode. Upon follow-up with the biomed, a photo of the defective motor protection switch was provided. In the photo, evidence of thermal damage was present on the component. The sample was not available to be returned for manufacturer evaluation. Machine files were requested but could not be provided; the system's sd card was found to be corrupted.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 10807647
• MDR Text Key: 215246984
• Report Number: 3010850471-2020-00009
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/09/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 10/19/2020
• 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