MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GP SERIES INFUSION SET, 1 SS Y; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 60693E

Device Problem Leak/Splash (1354)

Patient Problems Underdose (2542); Chemical Exposure (2570)

Event Date 10/24/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: an invalid lot # of 1016422 was provided by the initial reporter.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 gp series infusion set, 1 ss y experienced leakage.The following information was provided by the initial reporter: during the long and short infusion therapy, they realized that air vent (which is a part of set) is leaking out liquid drop by drop.They've faced three times regardless of slow or fast infusion rate.When detected, cap of air vent was open.Normally, set should not have been leaking out drug despite of cap is open.Another complaint is that silicone side was burst therefore medicine was leaking out from pump during infusion.Patient and nurses exposed chemotherapeutic agent directly- the drug dose which should be given wasn't administrated correctly- less dosage than planned- loss of sets.It has been faced both standard and light protection sets of alaris gp.

Event Description

It was reported that the gp series infusion set, 1 ss y experienced leakage.The following information was provided by the initial reporter: during the long and short infusion therapy, they realized that air vent (which is a part of set) is leaking out liquid drop by drop.They've faced three times regardless of slow or fast infusion rate.When detected, cap of air vent was open.Normally, set should not have been leaking out drug despite of cap is open.Another complaint is that silicone side was burst therefore medicine was leaking out from pump during infusion.Patient and nurses exposed chemotherapeutic agent directly- the drug dose which should be given wasn¿t administrated correctly- less dosage than planned- loss of sets.It has been faced both standard and light protection sets of alaris gp.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 11/20/2020.H.6.Investigation: one 60693e sample from lot 1016422 was received for investigation of which there are two child complaints associated; regarding leakage from an open air vent and regarding a leakage from the tubing below the flow stop component.The sample was received with residual fluid present in the line.No leakages were identified during examination of the sample and therefore it is not possible to link the sample to one issue or the other.The customer did provide a video with the initial feedback which confirmed their report of leakage from the air vent.Analysis of the video noted that the air vent cap was opened and that the fluid container in use was an iv bag.It was not possible to conclusively identify a root cause for this issue; however similar leakage can be replicated with an incorrect priming technique.A review of the production records for lot 1016422 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.

• Brand Name: GP SERIES INFUSION SET, 1 SS Y
• 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: 10909410
• MDR Text Key: 220253951
• Report Number: 9616066-2020-20457
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 60693E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other