MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV CKV 3 SS 20DP 20PK; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0500

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the gem v/nv ckv 3 ss 20dp 20pk experienced component separation and leakage.The following information was provided by the initial reporter: material no: 2426-0500 batch no: unknown.Tubing was being used for iv infusion per manufacturer recommendation when the tubing became disconnected at one of various hubs on the device in the middle of infusion, causing leaking of mediation/blood into the patients bed.There was no packaging saved indicating the lot number.The tubing is becoming disconnected at points that should be fused together.It did not lead to injury of the patient but it does lead to the patient not getting their complete dose of the medication being infused.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint of tubing became disconnected in the middle of infusion could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that the gem v/nv ckv 3 ss 20dp 20pk experienced component separation and leakage.The following information was provided by the initial reporter: material no: 2426-0500 batch no: unknown.Tubing was being used for iv infusion per manufacturer recommendation when the tubing became disconnected at one of various hubs on the device in the middle of infusion, causing leaking of mediation/blood into the patients bed.There was no packaging saved indicating the lot number.The tubing is becoming disconnected at points that should be fused together.It did not lead to injury of the patient but it does lead to the patient not getting their complete dose of the medication being infused.

• Brand Name: GEM V/NV CKV 3 SS 20DP 20PK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10793505
• MDR Text Key: 228259545
• Report Number: 9616066-2020-20256
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1