MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2500; SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040108-US

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 09/26/2021

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 the motor protection switch (mps) from an aquabplus 2500 sustained thermal damage.The biomed stated the display screen was blinking, and the machine would not go into operating mode.During evaluation of the system, the biomed discovered that the wire connectors (or cable lugs) on the back of the motor protection switch (mps) were burnt.There was no evidence of any burning smell, smoke, sparks, or flames.There were no alarm codes on the system.The biomed was unsure if the screen issues were caused by the burnt wire connectors on the mps, or the sd card which was reported to be corrupt.However, when the biomed replaced the sd card the screen issues went away.The biomed still intends to replace the mps and wires and confirmed that replacements were ordered.The biomed stated the thermal overload switch was not tripping, and there were no local power grid issues on the event date.Additionally, there were no blown fuses in the local power supply.The biomed was unable to download the machine files because the sd card was corrupt.The biomed stated they would provide photos of the thermal damage; but to date no photos have been provided.The biomed stated they would send back all replaced parts for evaluation.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Additional information: g1, h3 plant investigation: no parts were returned to the manufacturer for physical evaluation and the machine data files were not available as the sd card was found to be corrupt.A review of similar complaints was not required in this case.The reported failure patterns are known and are being addressed under capa projects.The most probable cause for the failure is poor electrical contact at the blade receptacles which are connected to the motor protection switch (mps).This results in thermal stress at the blade receptacles and may lead to heat damage.Despite the thermal damage found on the wire connectors, the machine was functional after replacing the sd card only.The device history record (dhr) review found the device to be conforming to specifications and released without any discrepancies.No separate review of the service history was required.As the failure patterns are known, no investigation of any single component was required.The review of the instructions for use (ifu) or service manual (sm) was not required because the failure pattern is known and is being addressed.A new design was released for the wiring and its included crimp connection of the blade receptacle.It is recommended to use the spare parts which are mentioned in a change notification that was issued.The complaint can be confirmed based on the provided information and previous complaint investigations with similar failure patterns.

Event Description

A user facility biomedical technician (biomed) reported that the motor protection switch (mps) from an aquabplus 2500 sustained thermal damage.The biomed stated the display screen was blinking, and the machine would not go into operating mode.During evaluation of the system, the biomed discovered that the wire connectors (or cable lugs) on the back of the motor protection switch (mps) were burnt.There was no evidence of any burning smell, smoke, sparks, or flames.There were no alarm codes on the system.The biomed was unsure if the screen issues were caused by the burnt wire connectors on the mps, or the sd card which was reported to be corrupt.However, when the biomed replaced the sd card the screen issues went away.The biomed still intends to replace the mps and wires and confirmed that replacements were ordered.The biomed stated the thermal overload switch was not tripping, and there were no local power grid issues on the event date.Additionally, there were no blown fuses in the local power supply.The biomed was unable to download the machine files because the sd card was corrupt.The biomed stated they would provide photos of the thermal damage; but to date no photos have been provided.The biomed stated they would send back all replaced parts for evaluation.There was no patient involvement associated with the reported event.

• Brand Name: AQUABPLUS 2500
• 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: 12643309
• MDR Text Key: 276823395
• Report Number: 3010850471-2021-00028
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/29/2021
• 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