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 2016-05-20 for SYSTEM, PERITONEAL, AUTOMATIC DELIVERY manufactured by Baxter Healthcare - Mountain Home.
[45576520]
(b)(4). An alarm indicative of a potential malfunction of the disposable cassette was reported. The device was 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
[45576521]
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm. The patient was connected at the time of the alarm. This occurred during drain five of five of peritoneal dialysis therapy. There was nothing unusual found during troubleshooting that would cause or contribute to the alarm. 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 | 1416980-2016-09477 |
| MDR Report Key | 5669293 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-27 |
| Date Mfgr Received | 2016-04-27 |
| Date Added to Maude | 2016-05-20 |
| 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 | 2016-05-20 |
| 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 | 2016-05-20 |