MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-21 for CT GAMMA DIALYZER (CT190G) 5M1546 manufactured by Nipro Corporation.
[18914486]
The facility reported that the patient was seen for a dialysis treatment. The treatment was initiated at 1030 with the patient's blood pressure (bp) of 134/76. At 1057, the patient complained of shortness of breath, was diaphoretic and wheezing. Oxygen at 2l/nasal cannula (nc) was initiated. Benadryl 25mg intravenous push (ivp) was given. The bp at this time was 84/52. The bp improved to 151/78 after the benadryl was given. The patient improved with a decrease in wheezing and improved color. The physician ordered benadryl 25mg ivp to be given prior to use of each new dialyzer. The dialysis treatment was continued with a flow rate at 200ml/minute. The patient was able to continue the treatment with the same dialyzer without further medical consequences.
Patient Sequence No: 1, Text Type: D, B5
[19033885]
The actual companion samples have been requested for evaluation. A follow-up report will be filed upon completion of an evaluation or if any additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2007-88826 |
| MDR Report Key | 1236570 |
| Report Source | 05 |
| Date Received | 2008-11-21 |
| Date of Report | 2007-05-15 |
| Date of Event | 2007-05-09 |
| Date Mfgr Received | 2007-05-15 |
| 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 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 (CT190G) |
| Generic Name | HOLLOW FIBER DIALYZER |
| Product Code | MSF |
| Date Received | 2008-11-21 |
| Catalog Number | 5M1546 |
| Lot Number | 07A25DX |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1288504 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | OHDATE-SHI, AKITA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-21 |