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 2016-05-19 for SYSTEM, PERITONEAL, AUTOMATIC DELIVERY manufactured by Baxter Healthcare - Mountain Home.
[45574980]
(b)(4). This is a report of use error where a patient replaced a solution bag during therapy. Use errors and proper user instructions are addressed in? The homechoice and homechoice pro systems patient at-home guide? , which is shipped with every homechoice device. The guide instructs the user not to attempt to reuse any disposable supplies. It warns the user not to replace empty solution bags or reconnect disconnected solution bags during therapy. Also, it warns the user that possible contamination of the fluid or fluid pathways can result if disposables are reused. A review of the label for the product family will be conducted. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[45574981]
It was reported that a patient reused single-use supplies during fill three of four of peritoneal dialysis therapy. The patient was connected at the time of the event. The patient replaced the heater bag during therapy. The technical service representative assisted with ending therapy. 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 | 1416980-2016-09438 |
| MDR Report Key | 5667984 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-04-25 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2016-05-19 |
| 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 | KINGA ALMASAN |
| 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 |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKK |
| Date Received | 2016-05-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Address | 1900 N HIGHWAY 201 MOUNTAIN HOME AR 72653 US 72653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-19 |