MAUDE Adverse Event Report: VIVONIC GMBH AQUAC UNO H; SUBSYSTEM, WATER PURIFICATION

Catalog Number G02000970-US

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 03/01/2021

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 aquac uno h portable reverse osmosis (pro) system sustained thermal damage sometime back in (b)(6) 2021 (exact date unknown).The biomed was not present when this happened, but they were told there was a power surge at the hospital.The power surge was followed by a burning smell that was coming from the power outlet the aquac uno h was plugged into.The biomed stated this occurred in the morning, before any patients were put on dialysis.After evaluating the system, it was discovered that one of the three prongs from the power plug of the aquac uno h was fried.The biomed said it looked blackened and melted.In addition, the power outlet itself was burnt, and a capacitor in the power supply blew.No other damaged components were found.The facility discontinued use of the pro device and it was taken to a nearby repair facility where it has remained since.The power supply and power cord were replaced at the repair facility, however, the electrical issues continued.Now, when the device changes modes, it pops the ground fault interrupter (gfi) wall breaker.The biomed has replaced the following parts with known good ones: the motherboard, the motor, and the heater.Each time modes are changed on the pro, it pops the wall breaker.Additionally, when the level rod float in the pro reaches level 3, this also pops the wall breaker.The biomed no longer has any of the parts that were replaced; they were all discarded.The biomed stated there were no blown fuses in the local power supply (at the hospital), at the time of the event.The biomed also confirmed that the thermal overload switch was not tripping.The issue has not been resolved and the biomed needs further assistance troubleshooting.No photos of the damaged components were available for review.The biomed was not aware of any smoke, sparks, or flames occurring at the time of the event.The ftp files have been provided for review.There was no patient involvement associated with the reported event.

Event Description

A user facility biomedical technician (biomed) reported that an aquac uno h portable reverse osmosis (pro) system sustained thermal damage sometime back in (b)(6) 2021 (exact date unknown).The biomed was not present when this happened, but they were told there was a power surge at the hospital.The power surge was followed by a burning smell that was coming from the power outlet the aquac uno h was plugged into.The biomed stated this occurred in the morning, before any patients were put on dialysis.After evaluating the system, it was discovered that one of the three prongs from the power plug of the aquac uno h was fried.The biomed said it looked blackened and melted.In addition, the power outlet itself was burnt, and a capacitor in the power supply blew.No other damaged components were found.The facility discontinued use of the pro device and it was taken to a nearby repair facility where it has remained since.The power supply and power cord were replaced at the repair facility, however, the electrical issues continued.Now, when the device changes modes, it ¿pops¿ the ground fault interrupter (gfi) wall breaker.The biomed has replaced the following parts with known good ones: the motherboard, the motor, and the heater.Each time modes are changed on the pro, it pops the wall breaker.Additionally, when the level rod float in the pro reaches level 3, this also pops the wall breaker.The biomed no longer has any of the parts that were replaced; they were all discarded.The biomed stated there were no blown fuses in the local power supply (at the hospital), at the time of the event.The biomed also confirmed that the thermal overload switch was not tripping.The issue has not been resolved and the biomed needs further assistance troubleshooting.No photos of the damaged components were available for review.The biomed was not aware of any smoke, sparks, or flames occurring at the time of the event.The ftp files have been provided for review.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The reported event could be confirmed by the machine files.A review of the machine files revealed no alarm code or malfunction of the machine for the event date of (b)(6) 2021; however, the exact event date was unknown.The overvoltage damage presumably occurred around (b)(6) 2021 to (b)(6) 2021.In the available machine data, the machine has not been running properly since then.According to the machine data, on (b)(6) 2021 every time the p1 pump starts, the machine experiences a power off.This indicates that the power supply is switched off externally (residual current circuit breaker) of the machine.The reported event was caused by a power surge from the power grid, and the machine power cord and the internal 24v power supply were damaged.The technician replaced the power cord, 24v power supply, motherboard, motor from pump p1 and the heater.But the ground fault indicator (gfi) was still tripping when the machine changed operation modes.Therefore, it is likely that the internal line, mounted after the power cord, is also damaged.It is advisable from a microbiological and economical point of view to scrap the machine completely and no longer use it for patient treatment.According to the risk assessment the risk is rated as broadly acceptable.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.A separate review of the repair history was not required.Reproducing the reported event is not possible.A review of the instructions for use (ifu) was not required because power surges are not user related.The reported event and the resulting error are too complex to be shown in the service manual.Based on the information available, the reported event was confirmed.

• Brand Name: AQUAC UNO H
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• MDR Report Key: 12503060
• MDR Text Key: 272415886
• Report Number: 3010850471-2021-00026
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• PMA/PMN Number: K143617
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02000970-US
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1