MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 24600-0007

Device Problem Complete Blockage (1094)

Patient Problems Underdose (2542); Insufficient Information (4580)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

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 as lvp 20d low sorb 3ss cv had flow issues when infusing taxol, leaving "140 cc" left in the bag.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag.(total volume 608cc)".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/14/2021.H.6.Investigation: one sample was returned from the customer.It was reported that 140 cc was left over in the bag.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with saline, and then infused with the pump dchu-0010 and pump module dchu-0014 at 125 ml / hr for 1 hour.The saline was flowed into an empty beaker.After 1 hour there was about 125 m/l of water.Fluids were running normally.The failure was unable to be replicated.A device history record review for model 24600-0007 lot number 20066468 was performed.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 because the failure was unable to be replicated.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - accuracy with lot #20066468 regarding item #24600-0007.H3 other text : see h.10.

Event Description

It was reported that the as lvp 20d low sorb 3ss cv had flow issues when infusing taxol, leaving "140 cc" left in the bag.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag.(total volume 608cc)".

• Brand Name: AS LVP 20D LOW SORB 3SS 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: 11128898
• MDR Text Key: 240992027
• Report Number: 9616066-2020-20729
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403241978
• UDI-Public: 50885403241978
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/19/2023
• Device Model Number: 24600-0007
• Device Catalogue Number: 24600-0007
• Device Lot Number: 20066468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1