MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-01 for AQUABPLUS 2500 G02040108-US manufactured by Vivonic Gmbh.
[98984541]
A manufacturer investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[98984542]
(b)(6), an installation logistics manager for vivonics, reported that an aquabplus 2500 reverse osmosis machine, located at a user facility, was removed from service due to a t1 test failure that occurred during set-up for hemodialysis (hd) use. It was reported to henry, by the user facility biomedical technician (biomed), that the sd card was burnt and there was an issue with the motherboard. This information was reported to fmcna rtg on (b)(6) 2018 during a conference call. The hd patients at this facility were able to receive treatment at another facility until the unit was repaired. There was no harm to any patients or individuals due to this event. There was no report of heat damage to the machine? S other components. The biomed replaced the sd card and motherboard to resolve the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. The sd card was stated to be available to be returned to vivonic for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010850471-2018-00001 |
| MDR Report Key | 7234041 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-01 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | VIVONIC GMBH |
| Manufacturer Street | KURUFUERST-EPPSTEIN-RING 4 |
| Manufacturer City | SAILAUF 63877 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63877 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUABPLUS 2500 |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2018-02-01 |
| Model Number | AQUABPLUS 2500 |
| Catalog Number | G02040108-US |
| Lot Number | N/A |
| Device Availability | Y |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIVONIC GMBH |
| Manufacturer Address | KURUFUERST-EPPSTEIN-RING 4 SAILAUF 63877 GM 63877 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-01 |