MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-20 for CT-190G CULLULOSE TRIACETATE 5M1546 manufactured by Nipro Corporation.
[995170]
The facility administrator contacted baxter to report that a patient developed an adverse reaction during use of ct 190g dialyzers. During a regular hemodialysis treatment approximately 4 minutes into the treatment, the patient developed acute shortness of breath, chest pressure and back pain. Shortly after that, the patient became restless. Patient lungs which were previously clear developed wheezing in all lobes. The patient was given benedryl 25 mg po, oxygen at 2 liters nasal cannula and solumedrol 40 mg iv push. The treatment was temporarily discontinued and the doctor notified. Per physician? S order the treatment with ct 190g dialyzer was ended and continued later with dry pack single use gambro24 dialyzer. Reportedly the patient recovered without further medical intervention an is currently doing well.
Patient Sequence No: 1, Text Type: D, B5
[8133419]
A study was conducted to evaluate the extracts from the ct-19g dialyzers, obtained during an on site visit. The companion samples were compared to a control lot to determine if there were any differences between the complaint sample and the control dialyzers. Two compounds were found to be unique to the complaint dialyzers and above the limit for analytical detection: heptanal and propanal. The heptanal and propanal in the solution from the complaint dialyzers were estimated at maximum concentrations of 0. 07 ug/ml and 0. 12 ug/ml, respectively. These two compounds were not used during the manufacturing of the dialyzer or its membrane. The manufacturing record, process inspection record and release inspection record of the complaint lots were reviewed and no aberrations were discovered. In additional, biological test were performed on the retained samples of the concerned lots and no abnormalities were found. Although there is no intravenous toxicity data available for either compound, both compounds are food additives permitted for direct addition to food for human consumption as a synthetic flavoring substance. Based on the nonclinical toxicology issues resulting from exposure to 1 l of dialyzer solution from the affected lots of ct190g dialyzers in addition, after review of the patient event logs with allergy and nephrology experts in the field, it was concluded that the ct-190g dialyzer complaint lots did not have any unique allergenic properties and did not contribute to these adverse events.
Patient Sequence No: 1, Text Type: N, H10
[8133870]
Baxter initiated an investigation upon received of the customer report. The actual and companion samples have been requested for evaluation. Baxter offered and conducted a customer visit on may 31, 2007. During a discussion with the facility's representatives the following facts were provided: although the patient has a history of allergic reaction to ct 190g dialyzer and other cellulose membrane dialyzers, this dialyzer was proved to provided adequate blood clearance for the patient, therefore the facility returned to using the ct 190g dialyzer. Reportedly, in 2007, the patient was seen in the emergency department due to facial swelling, pruritus and was treated for an allergic reaction. The investigation is still pending. If additional information is discovered a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2007-88831 |
| MDR Report Key | 1236367 |
| Report Source | 05,06 |
| Date Received | 2008-11-20 |
| Date of Report | 2007-05-09 |
| Date of Event | 2007-05-05 |
| Date Mfgr Received | 2007-11-21 |
| Date Added to Maude | 2008-11-28 |
| 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 0785794 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 0785794 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT-190G CULLULOSE TRIACETATE |
| Generic Name | 78MSF |
| Product Code | MSF |
| Date Received | 2008-11-20 |
| Catalog Number | 5M1546 |
| Lot Number | 06L11EX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1288301 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | OHDATE-SHI, AKITA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-20 |