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 06/10/2021

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 that an aquabplus 1500 had no display.There were no corresponding alarm codes on the system.This occurred on a day when the clinic was not open for dialysis treatments, and therefore, there was no patient involvement.During the biomeds inspection of the system, they identified burn marks on the 24 dc cable that connects from the 24v board to the motherboard.Burn marks were also visible on the motherboard itself.To resolve the reported issue, the biomed replaced the burnt parts with the motherboard and 24 dc cable from the second stage.During troubleshooting with a technician, the biomed was told this was an acceptable solution so long as the biomed didnt need to put the system into emergency mode 2.After performing the swap, the machine was able to operate in stage 1 (standard mode) without any further issues.The biomed confirmed there were no blown fuses in the local power supply, and there were no local power grid issues around the time of the event.No further damage was identified on any other machine components.The biomed affirmed that there was no evidence of any burning smell, smoke, sparks, or flames.They also confirmed that the thermal overload switch was not tripping.Photos of the burnt parts were provided for review, and the ftp files were also provided.The samples are available to be sent back for evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.The reported event was confirmed based on the provided pictures.The failure was attributed to a manufacturing failure.The reported event was caused by bad contacting due to low contact pressure between the 24v dc crimp connector and the power supply pin on the printed circuit board.The low contact pressure resulted in high contact resistance at the contact point, and high thermal power loss was indicated.The power loss led to the reported discolorations and dim display.During review of the machine files, there were many run-dry protection errors identified.These error codes are not related to the reported complaint event.The error codes can be attributed to unstable and insufficient feed flows.No investigation of the concerned components was necessary as the failure can be clearly identified and the failure pattern is known.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 separate review of the repair history was required.Reproducing the reported failure pattern was not necessary.Additionally, a review of the instructions for use (ifu) was not performed because the failure pattern was not user related.A review of the service manual revealed that a visual inspection of the device is part of the technical safety check.Based on the available information, the reported problem was able to be confirmed.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus 1500 had no display.There were no corresponding alarm codes on the system.This occurred on a day when the clinic was not open for dialysis treatments, and therefore, there was no patient involvement.During the biomed¿s inspection of the system, they identified burn marks on the 24 dc cable that connects from the 24v board to the motherboard.Burn marks were also visible on the motherboard itself.To resolve the reported issue, the biomed replaced the burnt parts with the motherboard and 24 dc cable from the second stage.During troubleshooting with a technician, the biomed was told this was an acceptable solution so long as the biomed didn't need to put the system into emergency mode 2.After performing the swap, the machine was able to operate in stage 1 (standard mode) without any further issues.The biomed confirmed there were no blown fuses in the local power supply, and there were no local power grid issues around the time of the event.No further damage was identified on any other machine components.The biomed affirmed that there was no evidence of any burning smell, smoke, sparks, or flames.They also confirmed that the thermal overload switch was not tripping.Photos of the burnt parts were provided for review, and the ftp files were also provided.The samples are available to be sent back for evaluation.

• 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: 12021986
• MDR Text Key: 256881453
• Report Number: 3010850471-2021-00018
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1