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

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.

Event Description

A medsun mandatory medwatch was received on 3/5/2020.Additional information reported that the event occurred at the hospital - critical care.

Manufacturer Narrative

H10 ¿ the lot number of the tego connector involved in the event was unknown.A single, new in sterile blister package, d1000 tego, of a recent lot sample, was returned for investigation.The lot number returned was 4187643.There were no visual anomalies or damage observed with the new d1000 tego.No mating devices were returned to evaluate with the new d1000 tego.Subsequent vacuum and pressure leak testing showed the d1000 tego met pressure and vacuum leak expectations outline in the product performance specification.The male and female thread geometry was measured and in all cases met design criteria.The complaint of disconnect could not be confirmed or replicated.The returned d1000 tego performed as expected and as designed.A device history review (dhr) for lot# 4187643 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Attachment: medsun mandatory medwatch report was received on 3/5/2020.

• Brand Name: TEGO® CONNECTOR
• Type of Device: SET, 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
• MDR Report Key: 9701659
• MDR Text Key: 179116970
• Report Number: 9617594-2020-00046
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Death
• Patient Age: 66 YR