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 06/10/2021

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 had no display. There were no corresponding alarm codes on the system. This occurred on a day when the clinic was not open for dialysis treatments, and therefore, there was no patient involvement. During the biomeds inspection of the system, they identified burn marks on the 24 dc cable that connects from the 24v board to the motherboard. Burn marks were also visible on the motherboard itself. To resolve the reported issue, the biomed replaced the burnt parts with the motherboard and 24 dc cable from the second stage. During troubleshooting with a technician, the biomed was told this was an acceptable solution so long as the biomed didnt need to put the system into emergency mode 2. After performing the swap, the machine was able to operate in stage 1 (standard mode) without any further issues. The biomed confirmed there were no blown fuses in the local power supply, and there were no local power grid issues around the time of the event. No further damage was identified on any other machine components. The biomed affirmed that there was no evidence of any burning smell, smoke, sparks, or flames. They also confirmed that the thermal overload switch was not tripping. Photos of the burnt parts were provided for review, and the ftp files were also provided. The samples are available to be sent back for evaluation.

• 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: 12021986
• MDR Text Key: 256881453
• Report Number: 3010850471-2021-00018
• 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: 07/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/17/2021
• 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: 07/06/2021
• 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