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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 CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
The device is not available for evaluation. Without the returned device a probable cause is unable to be established.
 
Event Description
The event involved a tego connector with an unknown list and lot number used in connection with unspecified baxter products on a pediatric patient. The patient¿s arterial blood line was connected to a tego connector that became at least partially disconnected and blood was lost was on the floor beneath the patient, which was not initially observed. The leak, at some point, possibly when the blankets were moved from the vascular access, became completely disconnected from the arterial bloodline. The nurses stated there were no alarms and the blood pump remained pumping. A code blue was called and the patient ended up in the pediatric intensive care unit. The patient received 2-3 units of blood and additional fluid replacement. The customer stated the patient was fine and dialysis treatment was resumed the next day.
 
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Brand NameTEGO CONNECTOR
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
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key11169535
MDR Text Key226776031
Report Number9617594-2021-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
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 Received12/21/2020
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: 01/14/2021 Patient Sequence Number: 1
Treatment
UNSPECIFIED ARTERIAL LINE, MFR UNK; UNSPECIFIED BAXTER PRODUCT
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