MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 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 05/24/2022

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 the motor protection switch (mps) from an aquabplus 1500 sustained thermal damage.Prior to the user facility opening for the day, the aquabplus 1500 had a t-1 failure of the p1 pump.According to the biomed, the thermal overload switch was tripping in stage 1.To temporarily resolve the issue, they reset it and were then able to use the reverse osmosis (ro) system for the remainder of the day.At the end of the day, as the biomed went to disinfect the ro, the display screen and the red/green light switch began to flash off and on.This happened multiple times until the system completely shut down.The biomed noted a mild burning smell at this time.During their inspection of the aquabplus system, the biomed identified evidence of thermal damage on the motor protection switch (mps) from stage 1.Both the switch and the wiring harness were burnt.The biomed got in touch with a water system specialist and was advised to switch the machine to emergency mode stage 2.The biomed confirmed the machine was operable in stage 2, and they replaced the switch and wiring harness a couple of days later when replacements arrived.The biomed confirmed there was a concentrate pressure low alarm that occurred at the time of the failure.There were no blown fuses in the local power supply and there were no local power grid issues around the time of the events.It was confirmed there was no evidence of any smoke, sparks, or flames.There was also no patient involvement; the biomed confirmed that no treatments were impacted, delayed, or cancelled.The biomed suspects there was ¿too much hard water being dumped into the ro¿.After replacing the mps and wiring harness, the machine issue was confirmed to be resolved.Upon follow-up, the biomed stated the water hardness has been within specification.The biomed stated they would provide photos of the damaged parts via email.Ftp files have already been provided, and the damaged parts were returned via returned goods authorization (rga).

Event Description

A user facility biomedical technician (biomed) reported that the motor protection switch (mps) from an aquabplus 1500 sustained thermal damage.Prior to the user facility opening for the day, the aquabplus 1500 had a t-1 failure of the p1 pump.According to the biomed, the thermal overload switch was tripping in stage 1.To temporarily resolve the issue, they reset it and were then able to use the reverse osmosis (ro) system for the remainder of the day.At the end of the day, as the biomed went to disinfect the ro, the display screen and the red/green light switch began to flash off and on.This happened multiple times until the system completely shut down.The biomed noted a mild burning smell at this time.During their inspection of the aquabplus system, the biomed identified evidence of thermal damage on the motor protection switch (mps) from stage 1.Both the switch and the wiring harness were burnt.The biomed got in touch with a water system specialist and was advised to switch the machine to emergency mode stage 2.The biomed confirmed the machine was operable in stage 2, and they replaced the switch and wiring harness a couple of days later when replacements arrived.The biomed confirmed there was a concentrate pressure low alarm that occurred at the time of the failure.There were no blown fuses in the local power supply and there were no local power grid issues around the time of the events.It was confirmed there was no evidence of any smoke, sparks, or flames.There was also no patient involvement; the biomed confirmed that no treatments were impacted, delayed, or cancelled.The biomed suspects there was ¿too much hard water being dumped into the ro¿.After replacing the mps and wiring harness, the machine issue was confirmed to be resolved.Upon follow-up, the biomed stated the water hardness has been within specification.The biomed stated they would provide photos of the damaged parts via email.Ftp files have already been provided, and the damaged parts were returned via returned goods authorization (rga).

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the reported event was confirmed based on the provided pictures and the sample investigation.Machine files were not available due to a corrupted sd card.The problem was most likely triggered by poor electrical contact at the l2 and l3 connection points between the cable lug of the connection cable and the plug-in contact on the motor circuit breaker.A review of the complaint history revealed that the reported event is unknown.The issue was resolved by replacing the motor protection switch (mps) and the connection cables.No device history record (dhr) review or reproduction was required.Review of the repair history revealed that the machine had a p1 pump that was found to be defective two days prior.Visual examination of the returned sample found thermal damage at the mps connector l2 and l3.No damage was found on the l1 connector.The housing of the motor circuit breaker was opened for further visual inspection.All three bimetal contacts showed no interruption or deformities.All three contact plates were in good condition and showed no traces of arcing due to increased contact resistance.The actuation mechanism and the bimetal contacts were also in good condition.Only the plastic housing on the l2 and l3 plug contacts showed signs of thermal damage.It looked like the mechanical spacing of the metal clamps, which are intended to provide a firm fit and good contact strength, were bent in cable lugs l2 and l3.This weakens contact resistance and can lead to higher power consumption and heat damage.However, the exact cause for the deformed l2 and l3 cable lugs could not be determined.One possible cause is a thermal stress-failure during the manufacturing process.A supplier nonconformity record (sncr) was created for further investigation of the deformed cable lug, to determine if there was a production failure with the cable lug.The reported event was confirmed based on the available information.

• Brand Name: AQUABPLUS, HF 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14625105
• MDR Text Key: 293493770
• Report Number: 3010850471-2022-00015
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/02/2022
• 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