MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number AC205

Device Problems Inaccurate Delivery (2339); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Cardiogenic Shock (2262); Respiratory Failure (2484)

Event Date 06/01/2020

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

A medsun mandatory medwatch report was received that stated "extremely critical post-operative emergency coronary artery bypass graft patient was transported to ct via bed.On return to patient room loss of arterial pulsatile flow noted.Standard treatment initiated which included fluid bolus.Trouble shooting of patient setup demonstrated that a clc broke off iv manifold sometime during or on return from ct trip.This breaking of iv apparatus resulted in patient not receiving high dose, high strength vasoactive and lifesaving medications.Stable iv flow re-established, but patient found to be in pulseless electrical activity.Code blue initiated.Patient expired despite heroic efforts.The event occurred on an unspecified day in (b)(6) 2020.The patient expired on (b)(6) 2020 and the cause of death was cariogenic shock, respiratory failure.There was patient involvement and adverse event.

Manufacturer Narrative

H10: there were no product samples returned for investigation.However, photographs were provided and evaluated by the manufacturing team.The photos show two nanoclave ports on the ac205 manifold are missing the nanoclave housing and seal.Evidence of breakage in the form of beach marks can be seen at the base of the nanoclave spikes.The device history review (dhr) for lot number 4161156 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.An attempt was made by icu medical to have the facility provide sister samples for investigation but the customer responded that no samples were unable to be provided.The reported complaint can be confirmed.The probable cause for the breakage is due to an unintentional force applied to the nanoclave bonded connection during use.

Manufacturer Narrative

H10 - additional information can be found in sections b5, d11 and h6 - patient codes.D11 - concomitant product: epinephrine, mfr unk; fentanyl, mfr unk; insulin, mfr unk; norepinephrine, mfr unk; vasopressin, mfr unk; normosol, mfr unk.H11 - h2: correction to previously submitted follow-up #1 medwatch report, additional information was selected instead of device evaluation.The h2 field has been corrected.

Event Description

Additional information was received regarding this complaint: medical interventions provided as a result of the event were: code blue, acls/bls, open chest resuscitation efforts with cardiac massage and internal defibrillation lasting approximately 25 minutes and iv fluid for volume.The medications infusing were: epinephrine 2mg/100ml, infusing at 3mcg/minute or 9ml/hr.; fentanyl 2500mcg/250ml, infusing at 50mcg/hr or 5ml/hr.; insulin 100 units/100 ml, infusing at (b)(4) units/hr or 4 ml/hr.; norepinephrine 8mg/250ml, infusing at 12 mcg/min or 22.5ml/hr.; vasopressin (b)(4) units/100ml, infusing at 0.04 units/min or 12ml/hr.; normosol at 10ml/hr.The set-up of the device: the customer reported that cardiac surgery racks are set up pretty standard in pre op.All iv meds run through a single access point unless incompatible.Examples that are frequently incompatible are amiodarone and bicarbonate.A typical set up has a primary iv tubing line that connects to a manifold that is taped to the iv rack.This is then connected via connection tubing to another manifold that is connected to a central line, a swan-ganz line.All meds are connected to those manifolds.Typically, the pressors (epinephrine, vasopressin, norepinephrine) and sedation (propofol, dexmedetomidine, and fentanyl) are connected to the manifold closest to the patient.The rest of the medications (insulin, tranexamic acid and nitroglycerine in the initial recovery) are connected to the first manifold closer to the iv pumps.These are infusing through the primary line that has normosol infusing at a rate of 10ml/hr.

• Brand Name: 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• 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: 10477468
• MDR Text Key: 205130608
• Report Number: 9617594-2020-00358
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)240701(10)4161156
• Combination Product (y/n): N
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AC205
• Device Lot Number: 4161156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUID BOLUS, MFR UNK; SEE H10; FLUID BOLUS, MFR UNK
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 120