MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2015-06-03 for HOMECHOICE PRO 5C8310R manufactured by Baxter Healthcare - Singapore.
[13499739]
(b)(4). The device was received and the evaluation is complete. This is an ancillary service event. The increased intra-peritoneal volume (iipv) event was identified through an event history log review. The homechoice device received a returned instrument testing evaluation (rite).? This evaluation included functional and electrical testing of the device and a visual inspection. A service history record review was performed and revealed no issues that could have caused or contributed to the reported issue. Upon conclusion of the investigation, the cause was determined to be use error, tidal total ultrafiltration removal set too low. The homechoice and homechoice pro apd systems patient at-home guide warns that "a total uf volume set too low can result in a gradual buildup of uf volume during therapy. This can result in an increased intraperitoneal volume (iipv) situation. " 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
[20362694]
During evaluation of a returned homechoice device, one increased intra-peritoneal volume event was identified which occurred in the therapy initiated on (b)(6) 2015 at 20:18:54. During night drain cycle five, the patient's ultrafiltration reading was 2601ml, indicating the home patient drained 2351ml more than their maximum programmed fill volume of 2500ml. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[20461384]
(b)(4). The device was received and is in the process of being evaluated. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2015-23957 |
| MDR Report Key | 4815922 |
| Report Source | 04,07 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-06-22 |
| Date Added to Maude | 2015-06-03 |
| 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 | 0 |
| Event Location | 0 |
| 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 - SINGAPORE |
| Manufacturer Street | 2 WOODLANDS INDUSTRIAL PARK |
| Manufacturer City | SINGAPORE 2573 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 2573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMECHOICE PRO |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKK |
| Date Received | 2015-06-03 |
| Returned To Mfg | 2015-05-12 |
| Catalog Number | 5C8310R |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - SINGAPORE |
| Manufacturer Address | 2 WOODLANDS INDUSTRIAL PARK SINGAPORE 2573 SN 2573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-03 |