MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2009-05-04 for U1104 1550 SINGLE PATIENT SYSTEM 5M5538 manufactured by Baxter Healthcare - Largo.
[1160028]
This is a report from baxter of a hemodialysis patient whom at the end of a therapy session on a single patient system, had increased weight instead of decreased weight. The patient experienced difficulty breathing and was administered oxygen and solucortef. The patient was then switched to a different dialysis machine where therapy was completed without further problems. The following additional information was provided: a fluid balance sheet was used to calculate the amount of fluid required. The treatment was programmed for 4 hours. The treatment lasted 1 hour in normal conditions, but is not clear how long after the ultra filtration module failed. The initial amount of fluid removal programmed for the treatment was 2 kg. The fluid removal rate displayed was 500 ml. A xenuim 130 dialyzer was used. The tmp was 0. 5. The arterial pressure was 150 mmhg. The venous pressure was 100 mmhg. The amount of fluid that the instrument display showed was not provided. The patient received saline given during prime and fluid given during rinse back. 100ml of saline was used during prime. The patient did not have any vomiting. The clinic uses one scale for all patients and the scale was calibrated and was not removed. Only the ultra filtration (uf) module of machine was retested during therapy.
Patient Sequence No: 1, Text Type: D, B5
[8394183]
The device has been taken out of service. A follow up report will be filed upon completion of the evaluation or if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00208 |
| MDR Report Key | 1374643 |
| Report Source | 01,05,07 |
| Date Received | 2009-05-04 |
| Date of Report | 2009-04-20 |
| Date of Event | 2009-04-16 |
| Date Mfgr Received | 2009-04-20 |
| Date Added to Maude | 2009-05-08 |
| 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 | KAREN KIRBY |
| 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 - 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 | U1104 1550 SINGLE PATIENT SYSTEM |
| Generic Name | 78FKP |
| Product Code | FKP |
| Date Received | 2009-05-04 |
| Catalog Number | 5M5538 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-04 |