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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported finding thermal damage on the motor protection switch (mps) from an aquabplus 2500. There were blackened/burnt wires on the back of the mps. Additional information was received from the area technical operations manager (atom), who was aware of the events. The atom stated the clinic lost power during operation. It was suspected that they lost 1 leg of the 3-phase system. The atom stated the issue was caused by a city transformer. Once power was restored to the facility, the hood of the aquabplus was lifted to inspect for damage. This is when the burnt wires were identified. Although the wires were damaged, the reverse osmosis (ro) system was still working. The atom stated that it was operating without any issues when they powered it back on, and there were no alarm codes displayed. Treatments were delayed due to the power outage, but there was no patient harm or injury. A few patients reportedly elected to go home without completing treatment, but the majority of patients waited for power to be restored. There were no adverse events due to any delayed or incomplete treatments. Furthermore, there was no direct patient involvement; the patients do not connect to the ro system. There was no evidence of any burning smell, smoke, sparks, or flames. The atom confirmed that the thermal overload switch was not tripping. The atom also reported that there were no blown fuses in the local power supply. As a precaution, the mps and burnt wires were replaced. Photos of the burnt wires were provided for review, and so were the ftp machine files. The atom stated they would contact their local water specialist contact to set up a returned goods authorization (rga) for the parts to be sent back for evaluation.

• Brand Name: AQUABPLUS 2500
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; director of quality; sailauf 63877 ; GM 63877
• Manufacturer (Section G): VIVONIC GMBH; kurufuerst-eppstein-ring 4; director of quality; sailauf 63877 ; GM 63877
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12586899
• MDR Text Key: 275123113
• Report Number: 3010850471-2021-00027
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/20/2021
• 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