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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
Device Problem Disconnection (1171)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
Mother of patient rang out. Patient was bleeding out of port. Discovered that spiros was still attached to patient but became disconnected at spinning end that attaches to tubing. Rn of patient notified. Patient reconnected to ivf. Lot number not known. Product discarded.
 
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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 Key12512189
MDR Text Key272693696
Report Number12512189
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 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Event Location Hospital
Date Report to Manufacturer09/22/2021
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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