MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20D 1CV 2SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

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 20d 1cv 2ss dehp free experienced component separation.The following information was provided by the initial reporter: material #: 2420-0007 batch/ lot #: unknown during pts auto bone marrow transplant, as i was flushing the last bag of cells i noticed the stop cock started leaking at the connection to the extension tubing (connected to the patient).As i told a coworker (orienting me to learn transplants) it was leaking, the extension tubing became disconnected from the stopcock and the end of the extension tubing landed in the trash, while the other end was still connected to the patient.Our assumption was that it was due to the pressure build up from the syringe and the stopcock, but we can't be 100% sure.Coworker assisted me in donning sterile gloves, unhooking the old tubing, cleaning the hub, priming new tubing, and connecting it to the patient and a new stop cock.I was able to finish the flush, however it seemed the pt may have lost approx.6ml of cells due to this event.The extension tubing was unable to be reused due to contamination.Bmt team, nursing leadership, and cell therapy tech notified of event.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-11-12.H6: investigation summary: customer reported the tubing set was leaking and then disconnected from the stopcock.Customer returned the affected stop cock and extension set.The set was infused with blue dye water from a syringe, and no leaks were observed.The stopcock was oriented and loaded through all possible ports, and no leak was observed.All four smart sites were primed with the syringe, and they all worked well.A second leakage test was conducted with the set submerged in water and loaded with 5 psi (dchu-0005 pressure gauge), and still there was no observed leak.The complaint of leakage could not be verified.A device history record review could not be performed on model 2420-0007 because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced component separation.The following information was provided by the initial reporter: material #: 2420-0007 batch/ lot #: unknown.During pts auto bone marrow transplant, as i was flushing the last bag of cells i noticed the stop cock started leaking at the connection to the extension tubing (connected to the patient).As i told a coworker (orienting me to learn transplants) it was leaking, the extension tubing became disconnected from the stopcock and the end of the extension tubing landed in the trash, while the other end was still connected to the patient.Our assumption was that it was due to the pressure build up from the syringe and the stopcock, but we can't be 100% sure.Coworker assisted me in donning sterile gloves, unhooking the old tubing, cleaning the hub, priming new tubing, and connecting it to the patient and a new stop cock.I was able to finish the flush, however it seemed the pt may have lost approx.6ml of cells due to this event.The extension tubing was unable to be reused due to contamination.Bmt team, nursing leadership, and cell therapy tech notified of event.

• Brand Name: GEM V/NV 20D 1CV 2SS DEHP FREE
• 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: 10892086
• MDR Text Key: 217997535
• Report Number: 9616066-2020-20428
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other