MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20D 1CV 2SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0007

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced component separation.The following information was provided by the initial reporter: complaint 2 of 3.Material no: 2420-0007 batch no: 20093140, unknown just wanted to pass along an issue xxxxxxx & her staff have been experiencing on c-pod with our iv tubing pmm# (b)(4).It is separating from where it is connected from the mfg.She said they had some instances last night & again today.I have one of defective ones in my cabinet but here is the lot no from one today.We have a few defective bd alaris pump infusion sets reference 2420-0007.I am not sure if other units are experiencing the same issues.The line is cut.I am not sure how many total products were found on the unit yesterday.I have pulled the defective infusion sets from our stock.These were like this in the original packaging-no appearance of tampering.I notified service center as well this evening.

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced component separation.The following information was provided by the initial reporter: complaint 2 of 3.Material no: 2420-0007 batch no: 20093140, unknown.Just wanted to pass along an issue xxxxxxx & her staff have been experiencing on c-pod with our iv tubing pmm# 31068.It is separating from where it is connected from the mfg.She said they had some instances last night & again today.I have one of defective ones in my cabinet but here is the lot no from one today.We have a few defective bd alaris pump infusion sets reference 2420-0007.I am not sure if other units are experiencing the same issues.The line is cut.I am not sure how many total products were found on the unit yesterday.I have pulled the defective infusion sets from our stock.These were like this in the original packaging-no appearance of tampering.I notified service center as well this evening.

Manufacturer Narrative

H.6.Investigation: customer reported there was a separation in the tubing and provided photos of the incident.The photo clearly shows a separation below the pumping segment.The root cause of this failure could not be identified without a failure investigation.A device history record review for model 2420-0007 lot number 20093140 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation other component - leak with lot #20093140 regarding item #2420-0007 h3 other text : see h.10.

• Brand Name: GEM V/NV 20D 1CV 2SS DEHP FREE
• 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: 11091483
• MDR Text Key: 250333830
• Report Number: 9616066-2020-20677
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20093140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1