MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-21 for CT-190G CELLULOSE TRIACETATE 5M1546 manufactured by Nipro Corporation.
[995818]
A facility administrator contacted baxter to report a second dialyzer reaction during use of ct 190g dialyzer. Patient was a male who was receiving dialysis treatment, and 4 minutes in to the treatment, developed acute shortness of breath, chest pain and back pain. The treatment was discontinued and the extracorporeal blood recirculated. The physician was notified that the dialyzer used this day was pre- processed, number of reuses 0. The doctor ordered solumedrol 40mg iv push, switch to a new dialyzer, gambro24, permanently and rinsed with 2. 0l normal saline solution prior to use. The symptoms significantly improved and the patient was able to complete the treatment without further clinical consequences. Additional information obtained during a customer visit. This patient has a history of allergic reaction due to cellulose dialyzer membrane.
Patient Sequence No: 1, Text Type: D, B5
[8137123]
Baxter initiated and investigation upon receiving this report. The actual and companion samples have been requested for evaluation. Baxter received one used dialyzer for this complaint/entry. An attempt was made to disinfect the sample using bleach solution method defined in rd-rq-c-005. The sample was still biohazardous after disinfection (blood was visible within dialyzer). It was observed that the sample had severe fiber damage that allowed disinfectant from the blood circuit to flow into dialysate compartment. Further analysis cannot be performed on this unit due to biohazardous condition of this sample. The investigation is still pending. If additional information is discovered a follow up report wil be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2007-88830 |
| MDR Report Key | 1236571 |
| Report Source | 05,06 |
| Date Received | 2008-11-21 |
| Date of Report | 2007-05-11 |
| Date of Event | 2007-05-10 |
| Date Mfgr Received | 2007-05-11 |
| Date Added to Maude | 2008-11-21 |
| 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 COPORATION |
| 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-190G CELLULOSE TRIACETATE |
| Generic Name | 78MSF |
| Product Code | MSF |
| Date Received | 2008-11-21 |
| Returned To Mfg | 2007-05-17 |
| Catalog Number | 5M1546 |
| Lot Number | 07A25DX |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1288505 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | OHDATE-SHI, AKITA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2008-11-21 |