MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 2000; SUBSYSTEM, WATER PURIFICATION

Model Number AQUABPLUS

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 07/14/2022

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 reported to fresenius technical support that an aquabplus, hf 2000 experienced no power to the display.Upon troubleshooting, a burnt wire was discovered on the power supply board.The biomedical technician removed the power supply from stage 2 and placed it into the stage 1.The biomedical technician also removed the cable from the power supply board to the mother board, and replaced the cable with the red/blue cable from stage 2 to resolve the reported issue and the machine was returned to service.There was no patient involvement, harm, or adverse events reported as a result of this issue.After the documented follow up attempts, no further information has become available and no response from the customer has been received.If additional information becomes available, the file will be updated and processed accordingly.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A review of the machine files was not needed as the described failure pattern is a known problem.The complaint investigation determined there was a bad/overheated electrical contact at the power supply unit on stage 1.The bad electrical contact is caused by an improper manufacturing process of this crimp and plug connection.The contact pressure inside the housing of this plug connector was too low at the power supply unit and this resulted in thermal stress until the contact get completely damaged over the time of device operation.This failure pattern is known and the implementation of corrective actions are currently in progress.The new manufacturing process is not approved yet and not available for possible spare part order.The device was built and delivered before the manufacturing process was reviewed within the performed root cause analysis.The failure pattern is known and a capa was assigned to this complaint record, any threshold exceedance is not relevant.Device history record (dhr) review was not performed.No separate review of the service history was required.Reproducing the reported failure pattern was not necessary, as the failure type is a known issue.Based on the available information, the reported problem was able to be confirmed.

Event Description

A user facility biomedical technician reported to fresenius technical support that an aquabplus, hf 2000 experienced no power to the display.Upon troubleshooting, a burnt wire was discovered on the power supply board.The biomedical technician removed the power supply from stage 2 and placed it into the stage 1.The biomedical technician also removed the cable from the power supply board to the mother board, and replaced the cable with the red/blue cable from stage 2 to resolve the reported issue and the machine was returned to service.There was no patient involvement, harm, or adverse events reported as a result of this issue.After the documented follow up attempts, no further information has become available and no response from the customer has been received.If additional information becomes available, the file will be updated and processed accordingly.

• 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: 15140907
• MDR Text Key: 297001518
• Report Number: 3010850471-2022-00017
• 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: 08/19/2022

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 Model Number: AQUABPLUS
• 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: 07/14/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/19/2022
• 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