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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number CH2000S-C
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/29/2022
Event Type  malfunction  
Event Description
Patient called registered nurse (rn) in during etoposide flush (approx. 5 minutes left). Line had come unattached and was backflow blood onto the sheets. Rn stopped the infusion, cleaned up bedding and helped locked patient. Upon further inspection of line, rn noticed that the spiros that was attached to the filter and the trifuse had broken off. The connection point would reconnect and spin as if the line had been "cracked" and wouldn't come undone, but it could be pulled off if enough pressure was used pulling backwards. Rn used 1,2 wipes, changed patient sheets, replaced chemo tubing, and saved the line in a biohazard bag.
 
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Brand NameICU MEDICAL
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key15239874
MDR Text Key298047263
Report Number15239874
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberCH2000S-C
Device Catalogue NumberCH2000S-C
Device Lot Number5877677
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2022
Event Location Hospital
Date Report to Manufacturer08/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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