MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 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 04/19/2022

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 an aquabplus 2000 sustained thermal damage.There were no alarms.The aquabplus system was in standby mode at the time of the discovery.The biomed stated they were replacing the level rod (with float) because the disinfection cycle would not complete.Upon lifting the cover, a burnt wire connector was identified on the stage 1 power switch.This occurred after the clinic had closed for the day and there was no patient involvement.There was no evidence of any burning smell, smoke, sparks, or flames.The biomed stated there was nothing wrong with the machine, other than the fact that it would not complete the disinfection cycle.The thermal overload switch was not tripping, and there were no blown fuses in the local power supply.The biomed also confirmed there were no local power grid issues at the time of the event.After replacing the level rod, the machine was able to complete disinfection.The burnt wire connector was not replaced.The biomed was unable to provide the ftp files.The level rod that was replaced was available to be returned for evaluation.

Manufacturer Narrative

Additional information: g1 plant investigation: no parts were returned to the manufacturer for physical evaluation.The reported event was confirmed by means of the provided picture and other information made available.The provided picture shows that unauthorized cable lugs were installed and attached to the motor protection switch.With these cable lugs, proper device performance cannot be guaranteed.A picture was reviewed from the final inspection of the device prior to use, and it shows that the device was manufactured with the correct cable lugs.It was reported that the monitor hood was only lifted due to a problem with the level rod.Afterwards, the discolored cable lug was found.The discoloration on the non-specified cable lug was caused by bad contacting due to too low contact pressure between the crimp connector/cable lug and its contact pin at the motor protection switch.The low contact pressure resulted in high contact resistance at the connection point and high thermal power loss occurred, resulting in the discoloration.The connections between the wiring and the cable lugs connected to the contact pins can loosen over the time from repeatedly lifting the monitor hood for maintenance.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 review for similar complaints was not required, and a review of the machine¿s repair history was not either.Reproducing the reported failure pattern was also not necessary.Based on the information available and the provided picture, the reported event was confirmed.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus 2000 sustained thermal damage.There were no alarms.The aquabplus system was in standby mode at the time of the discovery.The biomed stated they were replacing the level rod (with float) because the disinfection cycle would not complete.Upon lifting the cover, a burnt wire connector was identified on the stage 1 power switch.This occurred after the clinic had closed for the day and there was no patient involvement.There was no evidence of any burning smell, smoke, sparks, or flames.The biomed stated there was nothing wrong with the machine, other than the fact that it would not complete the disinfection cycle.The thermal overload switch was not tripping, and there were no blown fuses in the local power supply.The biomed also confirmed there were no local power grid issues at the time of the event.After replacing the level rod, the machine was able to complete disinfection.The burnt wire connector was not replaced.The biomed was unable to provide the ftp files.The level rod that was replaced was available to be returned for evaluation.

• Brand Name: AQUABPLUS, HF 2000
• 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: 14356722
• MDR Text Key: 291385511
• Report Number: 3010850471-2022-00010
• 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: 06/10/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/10/2022
• 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