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

Model Number 2420-0500

Device Problems Leak/Splash (1354); Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20123020.Medical device expiration date: 2023-12-15.Device manufacture date: 2020-11-27.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the as lvp 20d dehp 2ss cv tubing from lot 20123020 expanded while priming.Additionally, another tubing set from an unspecified lot broke apart during use.The following information was provided by the initial reporter: "event 1 it was reported that when priming the primary set, the rn noticed a bubble in the soft plastic of the tubing that gets inserted in the pump.Event 2: it was reported that a primary set broke where the soft plastic meets the hard blue plastic." "when priming the primary set the rn noticed a bubble in the soft plastic of the tubing that gets inserted into the pump.This tubing was never placed in a pump.The rn noticed the default prior to placing in the pump." "prior to this occurrence we had a primary set break where the soft plastic meets the hard blue plastic.We did not have a lot number on this malfunction.".

Manufacturer Narrative

H6: investigation summary: a complaint of component damage at the pumping segment was received from the customer.One sample was returned for investigation.Through visual inspection the customer complaint was verified.A piece of the pumping segment had a bulge.The set was attempted to be primed, but was unsuccessful.Fluid could not pass through the first smart site.The set could not be tested further.A device history record review for model 2420-0500 lot number 20123020 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15dec2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause was unable to be determined.A capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.

Event Description

It was reported that the as lvp 20d dehp 2ss cv tubing from lot 20123020 expanded while priming.Additionally, another tubing set from an unspecified lot broke apart during use.The following information was provided by the initial reporter: "event 1 it was reported that when priming the primary set, the rn noticed a bubble in the soft plastic of the tubing that gets inserted in the pump.Event 2: it was reported that a primary set broke where the soft plastic meets the hard blue plastic." "when priming the primary set the rn noticed a bubble in the soft plastic of the tubing that gets inserted into the pump.This tubing was never palced in a pump.The rn noticed the default prior to placing in the pump." "prior to this occurrence we had a primary set break where the soft plastic meets the hard blue plastic.We did not have a lot number on this malfunction.".

• Brand Name: AS LVP 20D DEHP 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
• MDR Report Key: 11532486
• MDR Text Key: 265643466
• Report Number: 9616066-2021-50521
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 37613203012448
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1