MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2008-03-18 for HOMECHOICE CYCLER-REFURBISHED 5C4471R manufactured by Baxter Healthcare.
[18591396]
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Patient Sequence No: 1, Text Type: N, H10
[18601946]
A nurse contacted baxter's technical svc ctr regarding a home pt on tidal therapy on a homechoice device. The nurse needed him to do a complete drain. The technical svc rep (tsr) called the home pt. Home pt was in fill 2. The fill volume was 1232ml. Tsr put the home pt into manual drain to drain everything out. The drain volume was 3736ml. The home pt's normal fill volume is 2300ml with a tidal volume of 50%. The total ultrafiltration per cycle is 62ml. No pt symptoms were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2008-00166 |
| MDR Report Key | 1017379 |
| Report Source | 04,05 |
| Date Received | 2008-03-18 |
| Date of Report | 2008-02-22 |
| Date of Event | 2008-02-22 |
| Date Mfgr Received | 2008-02-22 |
| Date Added to Maude | 2008-06-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, COMPL MGR |
| Manufacturer Street | 25212 W ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| 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 CYCLER-REFURBISHED |
| Generic Name | 78FKK |
| Product Code | FKK |
| Date Received | 2008-03-18 |
| Catalog Number | 5C4471R |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1015542 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-18 |