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 Patient Involvement (2645)

Event Date 11/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the inspection of an aquabplus 1500 system, it was reported that signs of heat damage were found.The reported damage was noted on the black connecting cable that connects the motor protection switch to the contactor, at the yellow female spade fitting of l2.To resolve the reported issue, the wire set was replaced.There were no reports of any patient harm, injury, or adverse event in relation to the issue.Though it could not be confirmed during follow-up, the sample was reportedly returned to the manufacturer for evaluation.

Manufacturer Narrative

H3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.A review of the complaint history revealed that the reported event is a known problem.The reported event was confirmed based on a photo that was provided of the damaged machine component.The provided machine files were not from an aquabplus system.However, a related complaint file contained machine files from the event date, and they were found to be corrupted.Therefore, the available files, which are likely not corrupted, were used for review.The operation mode reports from june 2020 to november 2020 were reviewed, and some impermissible power off/on cycles were identified in the data.The recommended restart time of 120 seconds (at minimum) was not respected, on at least six occasions.These impermissible switching cycles can lead to or contribute to heat damage of the cables.Another possible cause of the error can be resetting the tripped motor protection switch too early.Indications for this were found in the machine data.The review of the instructions for use (ifu) reveals that the waiting period after resetting a triggered motor protection switch is adequately addressed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.Based on the provided photo, the reported problem was able to be confirmed.The issue was resolved onsite by replacing the black connection wires.

• Brand Name: AQUABPLUS 1500
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• MDR Report Key: 10915157
• MDR Text Key: 218624403
• Report Number: 3010850471-2020-00010
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• PMA/PMN Number: K133829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• 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
• Device Age: MO
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1