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 |