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 2426-0500

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

(b)(6) hospital.Device expiration date: unknown.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 20dp ckv 2ss 117-in 20pk experienced tubing expansion/ballooning.The following information was provided by the initial reporter: complaint 2 of 2.Material #: 2426-0500, lot#: unknown.Rn reported that the tubing herniated when the start button was pushed on the alaris pump when starting a new infusion.The rn saw it immediately and was able to stop the infusion and able to set up a new tubing set.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced tubing expansion/ballooning.The following information was provided by the initial reporter: complaint 2 of 2.Material#: 2426-0500, lot#: unknown.Rn reported that the tubing herniated when the start button was pushed on the alaris pump when starting a new infusion.The rn saw it immediately and was able to stop the infusion and able to set up a new tubing set.

Manufacturer Narrative

Investigation summary: one sample was received for quality investigation.The customer complaint that the tubing herniating was confirmed by visual inspection.The silicone tubing was noticeably deformed in shape from the failure that the customer reported.No further damages or defects were observed.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.The root cause of this failure can be attributed to a failure of the component.The sample was able to prime and infuse without issues, and therefore it is determined that the silicone tubing failed.

• 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
• MDR Report Key: 11092372
• MDR Text Key: 230054865
• Report Number: 9616066-2020-20681
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 07613203020992
• 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: 01/08/2021

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: 2426-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1