MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for AMIA AUTOMATED PD CYCLER SET 5C5479 manufactured by Baxter Healthcare Corporation.
[185478829]
Therapy date - this events occurred approximately a week prior to the date and on (b)(6)2020. The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185478830]
It was reported that two (2) amia automated pd cycler sets leaked during dwell two of peritoneal dialysis therapy. The patient was connected at the time of the event. It was further reported that solution was leaking from the cycler door; however, the patient was unable to identify the exact source of the leak. There was no damage noted on the supplies. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01803 |
| MDR Report Key | 9891490 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-01 |
| Date Added to Maude | 2020-03-27 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Street | 1900 N HIGHWAY 201 |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMIA AUTOMATED PD CYCLER SET |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-27 |
| Model Number | NA |
| Catalog Number | 5C5479 |
| Lot Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |