MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. APPX 0.82 ML, 3 GANG 4-WAY NANOCLAVE STOPCOCK MANIFOLD W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number AC300

Device Problem Break (1069)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.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 customer reported one of the microclaves broke off an unspecified 3 port multiconnector while on a patient that was receiving life sustaining medication infusion.The medication being infused via the broken port was midazolam.Norepinephrine and fentanyl were also infusing via the multiconnector at the same time.The customer stated that there was back up of blood from the patient¿s central access out the side port, as well the patient had a temporary hypotensive event.This was immediately addressed by increasing the norepinephrine infusion.Additionally, they change their multiconnectors every 96 hours.There was blood loss and it was estimated to be less than 10mls as the nurse was actively providing care as she was switching the infusions.They immediately closed the clamp closest to the patient in order to prevent any further blood loss.They then removed the entire multiconnector, flushed the line and attached the norepinephrine directly to the vascular access site until another multiconnector could be prepared.The tubing was replaced, and therapy was resumed since a new syringe had already been prepared.The break happened when the nurse was attempting to remove the old tubing from the multiconnector.New syringe of drug and tubing was applied to a new multiconnector and infusions resumed.There was no physical defect/damage noted on initial assessment.

Event Description

Additional information was received from the facility's biomed department.He reported one of the clave connectors on the multi-port device failed during use.He mentioned that the examination of the components under light microscopy confirmed the presence of solvent bond cement on both mating surfaces.He also stated that the strength of the solvent cement had deteriorated.They also noted that the bonding area is smaller when compared similar connections and they may predispose this termination to failure.

Manufacturer Narrative

H10: no product samples were returned for investigation, however, three representative photographs were returned and evaluated.The first showed the middle port of a 3-port clave manifold separated at the bond.The following two photos show magnified views of what appears to be adhesive at the bond joint.From the photo it is not possible to determine the cause of the bond separation.A probable cause cannot be identified based on the information that has been provided and without return of the sample for detailed investigation.

Manufacturer Narrative

D10 - date returned to mfg: 11/12/2020.H10: (b)(4) used 3-port nanoclave manifold ext set was received and visually inspected.As received, the middle nanoclave port housing was separated from the base of the spike.The nanoclave spike was bent and the seal was missing.The probable cause of the bent spike is unknown.A gap in the adhesive was present on the separated nanoclave housing and the base of the spike.The reported complaint can be confirmed.The probable cause of the separated nanoclave body is due to an insufficient bond created during the assembly process.Additional information in d10, h3, and h6.

• Brand Name: APPX 0.82 ML, 3 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; colonia rancho santa clara, ma; ensenada, b.cfa. ; MX
• MDR Report Key: 10697372
• MDR Text Key: 213872095
• Report Number: 9617594-2020-00452
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AC300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FENTANYL, UNK MFG; MIDAZOLAM, UNK MFG; NOREPINEPHRINE, MFR UNK