MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-07-03 for HOMECHOICE 5C4471R manufactured by Baxter Healthcare - Largo.
[4516511]
During the evaluation of a returned homechoice device, a baxter service technician determined that the h failed volumetric accuracy testing. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[11968018]
(b)(4). The homechoice was returned to baxter and a device analysis is currently underway. Upon completion of the evaluation or if additional information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[17381585]
(b)(4). The homechoice (hc) device was returned and evaluated by the product analysis lab (pal). The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue. The external and internal inspection was performed and passed, along with all of the electrical testing. The fluid volumetric accuracy test was performed and the device failed, therefore, pal performed a more detailed inspection of the door assembly. The inspection showed that the door the piston foam was deteriorated. The evaluation revealed the cause of the failure to be the deteriorated piston foam. The piston foam was to be scrapped and the device was sent for servicing. Should additional relevant information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2014-21535 |
| MDR Report Key | 3914108 |
| Report Source | 04,07 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-06-11 |
| Date Mfgr Received | 2014-07-09 |
| Date Added to Maude | 2014-07-22 |
| 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 | CHRISTINA ARNT |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242703198 |
| Manufacturer G1 | BAXTER HEALTHCARE - LARGO |
| Manufacturer Street | 7511 114TH AVE. NORTH |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMECHOICE |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKK |
| Date Received | 2014-07-03 |
| Returned To Mfg | 2014-06-06 |
| Catalog Number | 5C4471R |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | 7511 114TH AVE. NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-03 |