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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
The device was discarded. Without the returned device a probable cause can not be established. A device history review (dhr) is unable to be performed due to no lot number being provided.
 
Event Description
The event occurred on a unknown date in 2018. The event involved a tego connector with unknown list and lot number that the customer reported during treatment, the patient was not feeling well and the nurse observed a pool of blood under the patient¿s chair. The customer stated that the blood leak was from the disconnection between the venous line, baxter artiset hd dnl hc bloodline, and the tego connector. The treatment was stopped and the patient became unconscious. The medical intervention consisted of 800 ml of saline and 4 units of a blood transfusion. The patient was stabilized after the event and was sent back to the ward. There was no more information provided.
 
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Brand NameTEGO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX 22790
Manufacturer Contact
christopher zanoni
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key9727373
MDR Text Key190681745
Report Number9617594-2020-00047
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2020 Patient Sequence Number: 1
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