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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported that the motor protection switch (mps) from an aquabplus 2000 was tripping in stage 1. The system had just finished heat disinfect and was in cool-down when it powered off. The biomed did not think there were any alarms that occurred in conjunction with the tripping mps. This occurred early in the morning, before any treatments had started. Some treatments were delayed by approximately 30 minutes, but all patients were able to complete their treatments after the reverse osmosis (ro) machine was fixed. To resolve the reported issue, the biomed replaced the mps. Upon further inspection of the mps, charring was found on one of the metal prongs. The biomed stated that it looked burnt (or charred); however, there was no evidence of any burning smell, arcing, smoke, sparks, or flames. There were no blown fuses in the local power supply, and there were no power grid issues in the area around the date of the event. The biomed reported that the mps was available to be returned for manufacturer evaluation. A photo of the burnt metal prong was provided for review.

Manufacturer Narrative

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

• Brand Name: AQUABPLUS 2000
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12775712
• MDR Text Key: 280505000
• Report Number: 3010850471-2021-00029
• 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: 12/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/16/2021
• 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