MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-01-11 for ACCURA HEMOFILTRATION SYSTEM 5M5660 manufactured by Baxter Healthcare.
[16829148]
A customer reported that a patient's death occurred during use of the instrument. Per the clinical director, the patient was a physician in very critical condition and had poor prognosis. Reportedly this patient was dialyzed on this instrument for a while and "the accura extended the life of the patient and the patient was going to die". However, during the event treatment there was a problem with the instrument (details were not provided). Reportedly, the patient's death occurred "around the labor day" (no exact date was provided). Currently the customer contacted baxter to request an evaluation of the device. No other information available at this time.
Patient Sequence No: 1, Text Type: D, B5
[17059011]
Baxter field service representative (fsr) evaluated the instrument at the customer location. During a visual inspection and dried blood was noted around the heparin pump. The heparin pump was found stuck in up position and the pressure transducer was damaged. During a functional inspection, the instrument failed trans-membrane pressure (tmp) sensor test in self-test mode. The fsr fixed the heparin pump, replaced the pressure transducer and performed functional evaluation per the instrument verification data sheet. The instrument performed all the tests within specification according to the manufacturing recommendation and it was released for patient use. Baxter is monitoring issues like this. An investigation still pending. Should additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00018 |
| MDR Report Key | 984576 |
| Report Source | 05,06,07 |
| Date Received | 2008-01-11 |
| Date of Report | 2007-12-12 |
| Date of Event | 2007-09-01 |
| Date Mfgr Received | 2007-12-12 |
| Date Added to Maude | 2008-01-30 |
| 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, MANAGER |
| 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 |
| Manufacturer Street | DOCK 10 |
| Manufacturer City | LARGOT 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 | ACCURA HEMOFILTRATION SYSTEM |
| Generic Name | 78FIR |
| Product Code | FIR |
| Date Received | 2008-01-11 |
| Catalog Number | 5M5660 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 953970 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening | 2008-01-11 |