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 02/15/2022

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus 1500¿s stage 1 thermal overload was tripping and alarmed with code ¿f-04-50-04¿.It was reported that the thermal overload in stage 1 was defective.This was determined because the original installer arrived to assist and noted that the system would run for ¿a bit¿, and then trip the thermal overload.The thermal overload was reset, but continued to trip.The reverse osmosis (ro) system was in supply mode at the time of the event.However, there was no indication of direct patient involvement, and no harm or adverse event reported as the issue occurred prior to treatment.Upon follow-up, it was confirmed there was voltage present on both sides of the motor protection switch (mps), indicating the mps was not the initial source of the problem.After the thermal overload was replaced, the motor protection switch began failing during the t1 test.There were no loose wires noted on the high voltage connections.The contacts of the defective mps in the on and off positions were measured, and l1 and l3 were found to be shorted open.There were no issues noted with the mains power.The motor protection switch was replaced and this resolved the reported issue.Following the repair, all functional checks passed and amperage tested within range.The faulty parts were returned for evaluation.During the download of the ftp files, it was noted the sd card was bad.A new card was ordered for replacement.Upon evaluation of the returned parts, thermal damage was identified on the bimetallic contacts from l1 and l3.

Manufacturer Narrative

Plant investigation: a sample was returned to the manufacturer for evaluation.The assumption from the site that initially the thermal overload was defective was most likely misinterpreted.The thermal overload tripped as side effect due to a phase missing.The device generated error message f-04-50-04 within a t1-test, and afterwards the motor protection switch (mps) was found damaged.The connections of l1 and l3 were found shorted open.Most likely, the bimetallic contacts of l1 became defective during the t1-test.The provided thermal overload switch and mps were investigated visually and functionally.The thermal overload switch was received in tripped condition.After resetting it, it worked correctly.The test function was tested and found to be working correctly.Therefore, the reported defect of the thermal overload switch could not be confirmed.However, the reported defect of the mps could be confirmed within the sample investigation.After disassembly, the bimetallic contacts l1 and l3 were found interrupted, showing signs of thermal damage.Most likely, a line conductor was missing which resulted in the inner bimetallic contacts breaking.The failure was caused by bad electrical contact of a line conductor.The failure pattern is known and is addressed in a capa project.The affected device was manufactured before implementation of the capa.A device history record (dhr) review was performed.The device was found to be conforming to the specifications and was confirmed to be released without any discrepancies.Review of the repair history was not required and reproducing the failure was not required.Likely failure causes could be determined and were assigned to bad contacting at the mps, frequent stop/starts of the pump due to run dry errors, and not allowing a cool down time of 120 seconds before resetting the mps.The reported complaint was confirmed based on the short description, the provided information, and the sample investigation.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14004026
• MDR Text Key: 288577140
• Report Number: 3010850471-2022-00007
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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