MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-11-20 for CT GAMMA DIALYZER (CT 190G) 5M1546 manufactured by Nipro Corporation.
[989023]
The administrator of the facility called the baxter account executive (ae) regarding a patient reaction. A ct 190 dialyzer was used during the patient treatment when the patient reaction occurred. The patient reported was experiencing breathing difficulties prior to the hemodialysis treatment. At approximately two minutes into the hemodialysis treatment, the patient reportedly was gasping for breath and said she could not breathe. The patient was placed on oxygen 2l/nc. The patient was unable to respond verbally. The blood pressure (bp) at the time of the event was 119/80. The pulse was unknown. Solu-medrol 40mg was given as an intravenous push (ivp). The rescue squad was called and the patient was transported to the hospital. The hospital admitted diagnosis was cardiac arrest. The patient expired in 2007 with the listed cause of dealth as cerebral vascular accident (cva).
Patient Sequence No: 1, Text Type: D, B5
[8134321]
The actual sample was discarded by the facility. There is no companion sample of the lot number available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2007-88823 |
| MDR Report Key | 1236366 |
| Report Source | 06 |
| Date Received | 2008-11-20 |
| Date of Report | 2007-05-15 |
| Date of Event | 2007-05-04 |
| Date Mfgr Received | 2007-05-15 |
| Date Added to Maude | 2008-11-20 |
| 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 | 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 | NIPRO CORPORATION |
| Manufacturer Street | 8-7, HANUKI-YACHI NIIDA-AZA |
| Manufacturer City | OHDATE-SHI, AKITA 0185794 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 0185794 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT GAMMA DIALYZER (CT 190G) |
| Generic Name | HOLLOW FIBER DIALYZER |
| Product Code | MSF |
| Date Received | 2008-11-20 |
| Catalog Number | 5M1546 |
| Lot Number | 06L11EX |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1288300 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | OHDATE-SHI AKITA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-11-20 |