CT GAMMA DIALYZER (CT190G) 5M1546

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1423500-2007-88826
MDR Report Key1236570
Report Source05
Date Received2008-11-21
Date of Report2007-05-15
Date of Event2007-05-09
Date Mfgr Received2007-05-15
Date Added to Maude2008-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKAREN KIRBY
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472704541
Manufacturer G1NIPRO CORPORATION
Manufacturer Street8-7, HANUKI-YACHI, NIIDA-AZA
Manufacturer CityOHDATE-SHI, AKITA 0185794
Manufacturer CountryJA
Manufacturer Postal Code0185794
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCT GAMMA DIALYZER (CT190G)
Generic NameHOLLOW FIBER DIALYZER
Product CodeMSF
Date Received2008-11-21
Catalog Number5M1546
Lot Number07A25DX
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1288504
ManufacturerNIPRO CORPORATION
Manufacturer AddressOHDATE-SHI, AKITA JA


Patients

Patient NumberTreatmentOutcomeDate
10 2008-11-21

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