MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000; SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040107-US

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 12/15/2021

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 an aquabplus 2000.The biomed stated the reverse osmosis (ro) system failed the t1 test and displayed the alarm code ¿f-04-50-04¿ while in supply mode.Per the biomed, the pump p1 was defective.It was discovered that the thermal overload switch was tripping in stage 1.The thermal overload was reset, and the system then passed the t1 test.Treatments were interrupted for approximately thirty minutes, but there was no patient injury or harm, and no missed treatments.There was no direct patient involvement.During troubleshooting, it was noted that the l2 cable from the motor protection switch (mps) to the power contactor was burnt and brittle.The biomed stated that it looked completely blackened.The biomed replaced all of the cables as a precaution and the ro has not experienced any further issues.In addition, the biomed ordered a new mps to have on-hand.To date, the biomed has not needed to replace this part.There was no evidence of any burning smell, smoke, sparks, or flames.In addition, there were no blown fuses in the local power supply and no known local power grid issues.The cables that were replaced had been discarded and were not available to be returned for physical evaluation.Although ftp machine files and a photo of the burnt cable lug were said to be available, they have not yet been provided.

Event Description

A user facility biomedical technician (biomed) reported finding thermal damage on an aquabplus 2000.The biomed stated the reverse osmosis (ro) system failed the t1 test and displayed the alarm code ¿f-04-50-04¿ while in supply mode.Per the biomed, the pump p1 was defective.It was discovered that the thermal overload switch was tripping in stage 1.The thermal overload was reset, and the system then passed the t1 test.Treatments were interrupted for approximately thirty minutes, but there was no patient injury or harm, and no missed treatments.There was no direct patient involvement.During troubleshooting, it was noted that the l2 cable from the motor protection switch (mps) to the power contactor was burnt and brittle.The biomed stated that it looked completely blackened.The biomed replaced all of the cables as a precaution and the ro has not experienced any further issues.In addition, the biomed ordered a new mps to have on-hand.To date, the biomed has not needed to replace this part.There was no evidence of any burning smell, smoke, sparks, or flames.In addition, there were no blown fuses in the local power supply and no known local power grid issues.The cables that were replaced had been discarded and were not available to be returned for physical evaluation.Although ftp machine files and a photo of the burnt cable lug were said to be available, they have not yet been provided.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, the reported failure pattern is a known issue.The failure was attributed to bad contacting (or low contact pressure) between the crimped cable lug of mains phase l2 and its contact pins at the motor protection switch (mps).The low contact pressure led to the reported tripping of the thermal overload and the charring of the cable lug from mains phase l2.As reported, there were no local power grid issues or problems with the fuses in the local power supply.Therefore, additional contributing factors cannot be determined.A capa was opened to address this failure pattern.The affected device was manufactured before implementation of the capa, and since that time, corrective actions have been defined and implemented.The design of the crimped cable lug was changed.The requested machine files and related pictures have not been provided.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.No investigation of the concerned components was necessary, and a separate review of the repair history was not required.Reproducing the reported failure pattern was also not necessary.A review of the instructions for use (ifu) and service manual (sm) were not performed because the reported error pattern is well known.Based on the information provided, the reported event was confirmed.

• Brand Name: AQUABPLUS 2000
• 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: 13170164
• MDR Text Key: 283264215
• Report Number: 3010850471-2022-00001
• 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,Followup
• Report Date: 02/09/2022

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: G02040107-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 02/09/2022
• 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