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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 D1000
Device Problem Disconnection (1171)
Patient Problems Death (1802); Blood Loss (2597)
Event Date 01/06/2020
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: prismaflex machine, product code: 106913, sn: (b)(4), mfr baxter; prismaflex hf1400 set, product code: 107142, lot number: 19g1003, mfr baxter; unspecified vascular catheter, mfr angiodynamics. The device was discarded. Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined. A device history review (dhr) could not be completed due to the unknown lot number. If additional information becomes available a supplemental report will be submitted.
 
Event Description
The event involved a tego connector that disconnected resulting in blood loss and death. The patient was admitted on (b)(6) 2020 with a possible non-st elevation myocardial infarction. The patient¿s line was place in the left internal jugular using an angiodynamics vas-cath catheter on (b)(6) 2020 and continuous renal replacement therapy (crrt) via a baxter prismaflex machine and prismaflex hemofilter set was begun on (b)(6) 2020 at 12m. It was stopped on (b)(6) at 3am and restarted at 3:45pm on (b)(6) 2020. The crrt ran until it clotted on (b)(6) 2020 and was restarted again at 1pm on (b)(6) 2020 for additional fluid removal. The event occurred around 20 hours later on (b)(6) 2020 at approximately 8:30am. At that time, the cardiac monitor alarmed bradycardic. The customer reported that it was approximately 10 minutes for the nurse to respond to the cardiac monitor alarm, assessed the patient¿s airway due to the patient previously self-extubating himself, and noted a pool of blood, with blood noted at the connection site. The nurse applied direct pressure, clamped the red and blue lines of the prismaflex set tubing and stopped the machine. It was found that the prismaflex tubing set was disconnected from the tego connector on the venous ¿blue¿ side of the tubing set. The tego connector was attached to the patient¿s catheter, which was covered by a blanket. The crrt was reported to be running at 200/min. It was reported that the blood loss was more than 200ml but the reporter did not believe it was 2 liters lost. The patient was reported to be a do not resuscitate (dnr) and was given a half ampule of atropine with the initial bradycardia. It was then confirmed with the wife for not aggressive resuscitation and the patient passed away. It was reported that the baxter prismaflex machine did not alarm for the disconnection as the pressure was not reached for the alarm to trigger. It was reported that the dressings on catheters and caps are typically changed weekly, on wednesday¿s, with the line being inserted on wednesday, (b)(6) 2020. The clinical condition of the patient prior to starting crrt with the prismaflex set was reported as, the patient self-extubated the prior day and was reintubated; the patient was receiving sedation and was restrained. There were no prior reports of leaking on this patient. The customer reported that the preliminary autopsy result was a possible heart attack but there are no final findings yet.
 
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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
christopher zanoni
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key9701659
MDR Text Key179116970
Report Number9617594-2020-00046
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberD1000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
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: 02/12/2020 Patient Sequence Number: 1
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