MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 117-IN 20PK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0500

Device Problem Complete Blockage (1094)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: one photo was attached by the customer which verifies the customer complaint that lipids were noted to be backing up in line in which iv kept beeping.No sample will be returned for investigation.A device history record review for model 2420-0500 lot number 20103030 was performed.The search showed that a total of 34563 units in 1 lot number was built on (b)(6) 2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no product will be returned per customer.No investigation was performed.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced flow issues.The following information was provided by the initial reporter: material #: 2420-0500, batch/lot # 20103030.Tpn/lipid solution set up.Rn had switched out the patient's pump for a new one.The iv kept beeping, iv team consulted to check the lua picc line.Iv team suggested that the blue filter on the lipids be moved to the port below the tpn line.Set was placed on new iv pump.Patient's picc line and both lumens were flushed and were patent with blood return.The set was reattached to the patient, but when pump was turned on it began beeping again, so it was disconnected from the patient and line was re-examined.Lipids were noted to be backing up into the line.Second rn took line out of the pump and it exploded lipids over both nurses.Patient was not harmed.

• Brand Name: GEM V/NV 20DP CKV 2SS 117-IN 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11159583
• MDR Text Key: 227049332
• Report Number: 9616066-2021-50030
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/26/2023
• Device Catalogue Number: 2420-0500
• Device Lot Number: 20103030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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 Age: 52 YR
• Patient Weight: 59