MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 2 GANG 4-WAY NANOCLAVE STOPCOCK MANIFOLD W/ROTATING LUER; STOPCOCK, I.V. SET

Model Number AC200

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Photographs were provided and evaluated.The photos show one list# ac200.A nanoclave is missing from the assembly.No other damage or anomalies can be seen in the images.One used 2 gang 4-way nanoclave stopcock manifold w/rotating luer (lot# unknown) was received and visually inspected.As received, one nanoclave was missing from the manifold and not returned.The stopcock port with the missing nanoclave was visually inspected and adhesive was present.No other visible damage or anomalies were identified.No mating devices were received.A torque test was performed on the remaining nanoclave/stopcock bond.The bond met product performance specifications and no separations occurred.The reported complaint can be confirmed however, without the return of the separated nanoclave body a probable cause cannot be determined.A device history review could not be conducted because a lot number was not identified.

Event Description

The event involved 2 gang 4-way nanoclave® stopcock manifold w/rotating luer that the customer reported one of the two stopcocks broke off the connection port to the iv tubing while unspecified iv vasopressors were infusing.Vasopressors and an unspecified amount of the patient's blood was noted to be leaking into the bed that necessitated a linen change.The patient became profoundly hypotensive for a short period of time until the staff could re-establish an iv site for the vasopressors.It was reported that interventions were required to prevent sustained harm to the patient.The device was replaced as quickly as possible and the patient required additional pushes of iv calcium chloride and phenylephrine to overcome the resulting episode of hypotension.The tubing and drug was replaced and therapy was resumed.No additional information has been provided.

• Brand Name: 2 GANG 4-WAY NANOCLAVE STOPCOCK MANIFOLD W/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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 11496242
• MDR Text Key: 251277338
• Report Number: 9617594-2021-00089
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

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 Model Number: AC200
• Device Catalogue Number: AC200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/16/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention