MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-26 for 1500 HEMODIALYSIS MACHINE 5M5538 manufactured by Baxter Healthcare - Largo.
[2118498]
On (b)(6)-2009, a biomed contacted a baxter technical service rep (tsr) regarding a 1500 hemodialysis instrument in which a pt coded during treatment and needs to have the instrument checked out. On (b)(6)-2009, a baxter field service engineer (fse) went to the facility, checked out the instrument and found no problem with the instrument. The device is operational, meets all functional specifications and is ready for use. On (b)(6)-2009, baxter product surveillance contacted the head nurse about this incident who reported that the event date was (b)(6)-2009 and that the pt died on (b)(6)-2009. The pt was a chronic dialysis pt for 6-7 years and was a very unstable pt. The pt was in the hospital already and receiving hemodialysis therapy. She stated that the pt was about an hour into treatment, her blood pressure and pulse dropped, she had a respiratory arrest, the treatment was stopped, she was removed from the machine, she then coded, was intubated, brought back to life and then transferred to the intensive care unit. She stated that the pt incident of going into respiratory arrest and coding was not because of the machine, dialyzers or blood tubing set. The pt was already very unstable. The pt became progressively more unstable until her death.
Patient Sequence No: 1, Text Type: D, B5
[9199138]
(b)(4). This mdr is being submitted as part of retrospective summary report# (b)(4). This report is being filed late to fulfill baxter's commitment to perform two year (b)(4). No problems were detected and the device was found to meet all functional specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-06555 |
| MDR Report Key | 2149018 |
| Report Source | 05 |
| Date Received | 2011-05-26 |
| Date of Report | 2009-08-14 |
| Date of Event | 2009-08-01 |
| Date Mfgr Received | 2009-08-14 |
| Date Added to Maude | 2011-07-07 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VIRGINIA MCKINNEY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472702835 |
| 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 | 1500 HEMODIALYSIS MACHINE |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DI |
| Product Code | FKP |
| Date Received | 2011-05-26 |
| Model Number | NA |
| Catalog Number | 5M5538 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Death; 2. Hospitalization | 2011-05-26 |