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

Catalog Number 2420-0007

Device Problems Complete Blockage (1094); Free or Unrestricted Flow (2945)

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

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that as lvp 20d 2ss cv had flow issues and a check valve malfunction.The following information was provided by the initial reporter: it was reported by the customer that medication poured into the primary iv fluid bag once it was spiked.The backcheck valve was defective.(b)(6) 2021 update: the 2nd event referenced occurred on (b)(6) 2021, and here are the notes: iv pump/channel or tubing malfunction caused primary fluid and secondary medication (chemotherapy gemzar) to infuse at a slower rate even though pump programmed accurately.Second rn verified mar data and used pump programming function through epic.Second rn also verify on pump and verified tubing and drip from bag.Duration of gemzar infusion orders stated not exceed a duration of 30 minutes.After going back to check on drip it was noted that primary ns flush bag of 250ml was almost empty and secondary chemotherapy bag had only infused very little.Approximately 35ml.Md's and pharmacist notified.Told that an error was made and duration for completion of gemzar would exceed the 30 minutes.Its worth noting that the (b)(6) event may or may not have been a result of the equipment but given the number of occurrences around a variety of tubes lately, we wanted to provide the information to stay ahead of any possible issues.

Event Description

It was reported that as lvp 20d 2ss cv had flow issues and a check valve malfunction.The following information was provided by the initial reporter: it was reported by the customer that medication poured into the primary iv fluid bag once it was spiked.The backcheck valve was defective.(b)(6) 2021 update: the 2nd event referenced occurred on (b)(6) 2021, and here are the notes: iv pump/channel or tubing malfunction caused primary fluid and secondary medication (chemotherapy gemzar) to infuse at a slower rate even though pump programmed accurately.Second rn verified mar data and used pump programming function through epic.Second rn also verify on pump and verified tubing and drip from bag.Duration of gemzar infusion orders stated not exceed a duration of 30 minutes.After going back to check on drip it was noted that primary ns flush bag of 250ml was almost empty and secondary chemotherapy bag had only infused very little.Approximately 35ml.Md's and pharmacist notified.Told that an error was made and duration for completion of gemzar would exceed the 30 minutes.It¿s worth noting that the 4/23 event may or may not have been a result of the equipment but given the number of occurrences around a variety of tubes lately, we wanted to provide the information to stay ahead of any possible issues.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-14.H6: investigation summary : one sample of primary infusion set 2420-0007, and an unidentified secondary infusion set was submitted for quality investigation.The customer complaint of backcheck valve / flow issues and backflow / unregulated flow could not be verified by testing.The primary infusion was visually inspected and no signs of physical damage was noted.The set was then primed and checked for leakage, air in line and occlusion.There were no issues identified in the primary set.The secondary set that was submitted with the primary set was primed and then connected to the primary set at the first smartsite.The secondary infusion bag, that was connected to the secondary set, was set at 9 in.Above the primary set infusion bag as instruction recommend.Fluid backflow into the primary set infusion bag was not seen.There were no additional flow issues observed in the infusion sets.A device history record review could not be performed on model 2420-0007 because a lot number was not provided by the customer.A root cause could not be determine because the reported failure could not be reproduced.H3 other text : see h10.

• 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
• MDR Report Key: 11944599
• MDR Text Key: 254594423
• Report Number: 9616066-2021-51261
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1