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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 4337813
Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2019
Event Type  malfunction  
Event Description
Nurse was getting the iv tubing ready to circle prime the chemotherapy. The nurse connected the spiros to the tubing and the spiros clicked like it would stay but it did not lock into place. The nurse noticed this before spiking the chemotherapy. Spiros lot number 4337813 alaris pump infusion set lot number (10)19085255.
 
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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 Key9391728
MDR Text Key168447455
Report Number9391728
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 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4337813
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 FDA11/26/2019
Event Location Hospital
Date Report to Manufacturer11/29/2019
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?
Type of Device Usage

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