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

Catalog Number G02040105-US

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

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

Event Date 08/24/2021

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 l2 cable going from the motor protection switch (mps) to the power contactor on an aquabplus 1500. Someone from the clinical staff noticed a yellow warning light on the reverse osmosis (ro) monitor on the treatment floor, and the biomed went in the back to further investigation. The biomed discovered that the concentrate pressure was too low, and the aquabplus 1500 was giving the alarm code w-02-51-03. Upon further inspection, the biomed found charring on the l2 cable at the mps. All cables connecting the mps to the power contactor were loose, but the charred (or burnt) cable was the loosest. The biomed disconnected power from stage 2 and then replaced the mps and the burnt cable. The spade connectors on the cables were then tightened, and the stage 2 pump resumed function. There was no patient injury or harm, and no missed treatments. Treatments were not impacted during the repair because the ro continued to operate under stage 1. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed confirmed there were no local power grid issues in the area around the time of the event. The biomed checked the local power supply and confirmed that there were no blown fuses there. It was also confirmed that the thermal overload switch was not tripping. The suspected cause of the failure was the loose cables. The loosest cable was the one that had thermal damage, and its suspected that arcing may have occurred at this connection. A photo of the charred cable was provided for review, as were the machine data files. The mps and burnt cable were not available to be returned for manufacturer evaluation as they were discarded.

• 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: 12457524
• MDR Text Key: 270983063
• Report Number: 3010850471-2021-00024
• 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: 10/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/10/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 09/22/2021
• 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