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

Catalog Number G02040107-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2020

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's biomedical technician (bmt) reported that an aquab plus 2000 blew a switch during the t1 test at start-up.The t1 test is an automatic test performed at start-up to verify proper functionality of the machine¿s components.The blown switch that occurred during the test resulted in heat/burn damage on the motor circuit breaker.The burn damage was not widespread.The bmt reported that the damage was isolated to the switch at the connector, and on one of the connected wires.The bmt provided pictures which showed burn damage on the switch, and blackening on the end of the wire connection.The machine was plugged into a breaker box/surge protector and the motor circuit breaker was confirmed to be an original fresenius part.There was no smoke, burning smell, flame, spark, or arcing noted.No other parts were found to be damaged.The bmt replaced the motor circuit breaker and the connected wires to resolve the reported issue.Functional checks were completed following the repair, and the machine was confirmed to be operating properly.The bmt reported that the sample has been returned to the manufacturer.There was no patient involvement associated with the event.

Manufacturer Narrative

Additional information: concomitant medical products, device evaluated by mfr: plant investigation: the reported event was confirmed based on investigation of the returned sample.Many power off/on cycles were identified in the available machine files (229 times in around 2 hours, on the reported event date).The power off/on cycles were most likely caused by an unstable power grid, blown fuses or inadmissible off/on switching by the operator/user.The device history record related documentation has been reviewed.The device has been found to be conform to the specification and has been released without any discrepancy.Review of the repair history was not required, nor was replication of the reported failure.The reported event could clearly be seen by the provided pictures.During functional examination of the returned components, a resistance measurement of the contacts showed no anomalies.All three (l1, l2, l3) resistance contacts were in the on position, and high-impedance was in the off position (on the switch).A visual examination showed no anomalies at the contact plates or at the operating mechanism.The plug-in connector of phase l3 and the connected flat connector showed mechanical damage caused by high contact resistance and current flow.In addition, the connection cable of l3 was loose.The review of the instructions for use (ifu) revealed that the reported failure type can be user related and isn't adequately addressed in the current version.Changes will be considered in regular updates of ifu.The missing information was communicated on july 16th, 2019 via change notification (cn) 618.Due to the loose cable of phase l3, the motor protection switch was not balance loaded and shut off the machine as intended.The bmt resolved the issue by replacing the connection cable between the contactor and the switch, and the motor protection switch itself.Though there was no patient involvement, the residual risk was reported to be broadly acceptable after assessment.

• Brand Name: AQUABPLUS 2000
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• MDR Report Key: 9934509
• MDR Text Key: 186787262
• Report Number: 3010850471-2020-00004
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• PMA/PMN Number: K133829
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Device Age: MO
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1