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U.S. Department of Health and Human Services

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

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ICU MEDICAL, INC. SPIROS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 5239751
Device Problems Disconnection (1171); Reflux within Device (1522)
Patient Problem Insufficient Information (4580)
Event Date 08/19/2021
Event Type  malfunction  
Event Description
Parent rang bell and stated that the patients tubing had become disconnected. This rn immediately paused the infusions and asked for other rn's assistance since chemo was involved. Methotrexate and iv fluids were infusing into the patient when the disconnect happened. The spiros cap connecting the fluid line to the patient became disconnected from the patient. No chemo was spilled, however the patient started backing the tubing up with blood. Rn's then obtained another fluid bag with new tubing and restarted the infusion.
 
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Brand NameSPIROS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key12466631
MDR Text Key271285079
Report Number12466631
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 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5239751
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2021
Event Location Hospital
Date Report to Manufacturer09/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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