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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

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 finding burnt cables on an aquabplus 2000. Upon follow-up, it was confirmed that thermal damage was found on the cables between the motor protection switch and the power contactor. The burnt cables were identified during the technical safety check. To resolve the reported issue, the biomed replaced all three cables. However, the following day the biomed realized the pump was rotating backwards. When reassembling the parts (post repair), were placed in the wrong positions. To fix this, the biomed swapped them and the pump began rotating in the correct direction. At the time of follow-up, the system was reported to be fully operational. The biomed stated there have been no further issues. The damaged cables were reported to be available for evaluation. The biomed was unable to provide ftp machine files review because the sd card was reportedly corrupt. There was no patient involvement associated with the reported event.

• Brand Name: AQUABPLUS 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11867046
• MDR Text Key: 252069929
• Report Number: 3010850471-2021-00011
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/21/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 05/31/2021
• 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