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 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The review of the complaint history revealed that the reported event is a known problem.The reported event was confirmed based on a photo that of the damaged machine component and provided machine files.The failure can be attributed to a contacting problem between the blade receptacle and the contact pin of mains phase l2 of the motor protection switch.The picture shows a slight discoloration of the blade receptacle of l2 which is substantiating this assumption.Error code f-04-51-04 stops the device as intended.In a worst-case scenario, the actual treatment could be interrupted, and planned treatments could be delayed.The reported error code was identified nine times on the reported event date.F-04-51-04 is indicates a defect of the second stage booster pump p1s during the t1 functional start up test.Most likely, an improper connection of the blade receptacle on contact pin l2 of the motor protection switch led to contact resistance.Therefore, thermal stress and damage was applied to the wiring and receptacle, the contact pin, and the internal bimetallic switches of the motor protection switch.Due to this thermal stress and damage, the thermal overload and the motor protection switch of the second stage tripped.Also, strong forces are attached to the internal wiring on the motor protection switch when the monitor hood is lifted up due to operational qualification and/or service activities.As a result, the blade receptacle can loosen.To resolve the problem, a new motor protection switch and the pump connecting cable were replaced.The mentioned pressure gauge cannot be identified as failure source for the reported event.Based on the provided photo, the reported problem was able to be confirmed.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus 1500 had defective p1s and the system alarmed with the following code: f-04-51-04.There was a thermal overload that occurred in stage 2, and stage 2 was tripped and then reset.The stage 2 power switch was tripping on the pumps start.It was suspected that the motor protection switch had also failed.Additionally, the pre-p1s pressure gauge had been readying 0 for a couple of days.Decalcification was recommended in addition to checking the function of the softener.The motor protection switch was replaced, along with the pressure gauge.After replacement of the parts, the unit was returned to service.Upon follow-up with the biomed, it was reported that the system was fixed and in "normal operating mode".It was also reported that the replaced parts were being dropped off.There was no reported patient involvement associated with the event.In the initial reporting, a photo of the motor protection switch showed a slight discoloration on the blade receptacle of l2.Though multiple follow-up attempts were performed, no additional information could be obtained.

• 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: 11387968
• MDR Text Key: 233890690
• Report Number: 3010850471-2021-00007
• 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
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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
• Device Age: MO
• Date Manufacturer Received: 02/02/2021
• 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
• Patient Sequence Number: 1