CRIT-LINE BLOOD CHAMBER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-01 for CRIT-LINE BLOOD CHAMBER manufactured by In-line Diagnostics.

Event Text Entries

[17765945] On monday, september 29,1997, a facility was being dialyzed. The pt began to experience symptoms of hemolysis. There are contradicting stories as to when hemolysis occurred. One nurse said the hemolysis occurred within the first hour to hour and a half, while another nurse said the hemolysis occurred after saline was infused to alleviate a hypovolemic event. Two similar events occurred previously; (one prior to may 1997 and another in may 1997). In line diagnostics corp. (idc) was not notified of any incidents until september 29,1997. All three pts involved were taken off dialysis and monitored for further complications. All pts fully recovered. In may, 1997 the facilities med director and his staff conducted a thorough investigation with no absolute conclusion as to the cause of these three events. When the third event occurred in september, the med director reported to co that he found three commonalities in each of the three cases: 1. A baxter ct190 dialyzer was used. 2. A cobe c3 machine and tube set was used. 3. A disposable blood chamber from idc was used. Add'l items noted were: a. There was a leak in the dialysis circuit (either between the dialyzer and the blood chamber or between the blood chamber and the tubing set) b. The renalin flush performed prior to the pt hook-up, was conducted a second time (or more) after failing the initial renalin test. C. In each instance, the dialyzer, tubing set, and blood chamber was discarded by facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721979-1997-90001
MDR Report Key137130
Date Received1997-12-01
Date of Event1997-09-29
Date Reported to Mfgr1997-09-29
Date Added to Maude1997-12-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRIT-LINE BLOOD CHAMBER
Generic NameCRIT-LINE BLOOD CHAMBER
Product CodeJPI
Date Received1997-12-01
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberFIRM'S REFER NUMBER #2231D
Device Availability*
Device Eval'ed by Mfgr*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key133949
ManufacturerIN-LINE DIAGNOSTICS
Manufacturer Address4646 SOUTH 1500 WEST, SUITE 160 RIVERDALE UT 84405 US
Baseline Brand NameCRIT-LINE BLOOD CHAMBER
Baseline Generic NameCRIT-LINE BLOOD CHAMBER
Baseline Model NoNA
Baseline Catalog NoNA
Baseline IDFIRM'S REFER NU


Patients

Patient NumberTreatmentOutcomeDate
10 1997-12-01

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