MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that as lvp 20d 2ss cv tubing was kinked.The following information was provided by the initial reporter: material no: 2420-0007, batch no: 20083469.It was reported that tubing kinked below the drip chamber.Nurse witnessed issue while in progress of priming primary line.Describe reported problem/event in detail: (use another sheet if necessary).Nurse was priming primary tubing and noticed saline was not flowing well, and noticed area of pinching below drip chamber.

Manufacturer Narrative

H.6.Investigation: one sample was returned for investigation.Through visual inspection of the sample, a kink was found at the connection site of the drip chamber and the rest of the set.The customer complaint was verified.The kink could not be smoothed out, but the set was successfully primed and infused.A device history record review for model 2420-0007 lot number 20083469 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 tubing kinked with lot #20083469 regarding item #2420-0007.The root cause for this defect is coiling and packaging set prior to solvent fully drying.H3 other text : see h.10.

Event Description

It was reported that as lvp 20d 2ss cv tubing was kinked.The following information was provided by the initial reporter: material no: 2420-0007, batch no: 20083469.It was reported that tubing kinked below the drip chamber.Nurse witnessed issue while in progress of priming primary line.Describe reported problem/event in detail: (use another sheet if necessary).Nurse was priming primary tubing and noticed saline was not flowing well, and noticed area of pinching below drip chamber.

• Brand Name: AS LVP 20D 2SS CV
• 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: 11083709
• MDR Text Key: 245042621
• Report Number: 9616066-2020-20655
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/29/2023
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20083469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1