MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 1500 SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040105-US

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/30/2021

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 that an aquabplus 1500 was experiencing a power problem. The biomed received a call from the facility when they were opening, reporting that the reverse osmosis (ro) system would not power on. During their troubleshooting, the local staff relocated the stage 2 power supply board and cable (going to the motherboard), to stage 1. This resolved the power issue. After doing this, the t1 test was completed without any problems. The biomed went to the clinic to evaluate the ro system. The biomed stated there were no alarm codes. Per the biomed, this was strictly a power-related issue. Upon further inspection, burn marks were identified on the cable connector that goes to the power supply motherboard. Replacement parts (a power supply and cable) were ordered. The reported failure resulted in a minor treatment delay (approximately 15 minutes); however, all patients were able to complete their treatments and none were sent home or to a different clinic. There was no patient harm. Other than the burnt cable connector, there were no additional damaged components found. There was no burning smell, smoke, sparks, or flames. In addition, there were no local power grid issues in the area. The biomed confirmed there were no blown fuses in the local power supply, and the thermal overload switch was not tripping. At the time of follow-up, the machine was fixed and fully operational. The parts were available to be returned for evaluation; the biomed stated they were packaged and ready to be sent back. Photos of the burnt cable connector were provided for review. The biomed was unable to provide the ftp machine files. There was no patient involvement associated with the reported event; the reported failure occurred prior to the start of any treatments.

• Brand Name: AQUABPLUS 1500
• 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: 12503057
• MDR Text Key: 272415893
• Report Number: 3010850471-2021-00025
• 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: 10/14/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040105-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: 09/24/2021
• 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