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 06/05/2021

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 2000 would not power on.The local staff had indicated there was a power disruption of unknown cause and the facilitys generator kicked in.The generator reportedly gave a power surge to the system, causing the 24 v power supply unit on stage 1 to fail.The power supply failure then caused the (3.15 a) fuse that feeds it to blow.They determined this because the fuse was replaced before the power supply, and the fuse blew again.Upon further inspection it was noted that the cable, which connects from the motor protection switch (mps) to the power contactor, was burnt.The 24 v supply was taken from the side and placed on the side.This allowed the system to operate normally.The facility ordered a new 24 v supply, and the cable that feeds the motor protection switch (mps).There were no corresponding alarm codes that occurred during the failure.There was no report of smoke, and there was nobody in the water room at the time of the event to notice any sparks.The failure did not occur while patients were undergoing treatment, and therefore, there was no patient involvement.Once the replacement parts arrive, the 24 v supply from the primary stage will be returned for evaluation.A sample is expected to be sent back.

Manufacturer Narrative

Additional information: h3 plant investigation: the reported event was confirmed based on the provided machine files and pictures.The discolored cable lug (identified during troubleshooting) was attributed to bad contacting due to low contact pressure between the crimp connector and the contact pin at the motor protection switch.The low contact pressure resulted in high contact resistance at the connection point, and a high thermal power loss was indicated.This connection can get loose over the time from service maintenance and lifting the monitor hood.The blown 3.15amp fuse of the 24vdc power supply can be attributed to the power surge caused by the generator at the local power supply.It is believed that this power surge led to the breakdown of the device.To resolve the problem, the 24vdc power supply of the second stage was moved to the first stage until the replacement power supply was delivered to the user facility.A review for similar complaints was not required in this case.The design of the crimped cable lug will be changed in the future design.The device history record(s) were reviewed; the device was found to be conforming to the specifications and released without any discrepancies.Review of the repair history was not required, nor was a reproduction of the failure.The reported failure pattern is known.The reported event did not result in any corresponding error codes.Based on the available information, the reported event was able to be confirmed.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus 2000 would not power on.The local staff had indicated there was a power disruption of unknown cause and the facility¿s generator kicked in.The generator reportedly gave a power surge to the system, causing the 24 v power supply unit on stage 1 to fail.The power supply failure then caused the (3.15 a) fuse that feeds it to blow.They determined this because the fuse was replaced before the power supply, and the fuse blew again.Upon further inspection it was noted that the l2 cable, which connects from the motor protection switch (mps) to the power contactor, was burnt.The 24 v supply was taken from the b2 side and placed on the b1 side.This allowed the system to operate normally.The facility ordered a new 24 v supply, and the cable that feeds the motor protection switch (mps).There were no corresponding alarm codes that occurred during the failure.There was no report of smoke, and there was nobody in the water room at the time of the event to notice any sparks.The failure did not occur while patients were undergoing treatment, and therefore, there was no patient involvement.Once the replacement parts arrive, the 24 v supply from the primary stage will be returned for evaluation.A sample is expected to be sent back.

• Brand Name: AQUABPLUS 2000
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• MDR Report Key: 12021968
• MDR Text Key: 257107596
• Report Number: 3010850471-2021-00017
• 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: 07/23/2021

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?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1