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

Catalog Number G02040108-US

Device Problems Smoking (1585); Arcing (2583); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

An area technical operations manager (atom) reported that an aquabplus 2500 from one of their facilities had a motor protection switch failure. It was reported that the power on the system tripped and the machine would not run. Simultaneously, smoke was seen coming from the thermal contactor below the motor protection switch. The atom stated that it was not a lot of smoke and confirmed that the smoke detector did not go off. A burning smell was also noticed. The atom tried turning the machine back on to run it in emergency mode. As they did this, sparks and arcing were noted coming from the wires down by the contactor. The atom stated that the hood of the reverse osmosis (ro) system was closed, so they were unable to see inside of it. There were no reports of flames. In addition, there were no reported alarms. Patients were in treatment when the failure occurred, but there were no adverse events as a result. The atom stated the facility has two separate ro systems, and the patients who were in treatment were relocated to the other half of the treatment floor where they utilized the other ro system to complete their treatments. The event did not result in any incomplete treatments. To repair the aquabplus 2500, the atom replaced the motor protection switch, the thermal contactor, the relay, and ancillary wiring. The atom stated the damaged parts were returned for manufacturer evaluation. The aquabplus 2500 was returned to service and reported to be fully operational. As patients do not hook up to ro systems, there is no direct patient involvement associated with this event.

• 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: 11605865
• MDR Text Key: 243494082
• Report Number: 3010850471-2021-00008
• 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,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 04/13/2021
• 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