MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING; INTRAVASCULAR ADMINISTRATION SET

Model Number 11532269

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354)

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

Event Date 08/27/2021

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.

Event Description

It was reported gem v/nv 20dp ckv 2ss 0.2mf low sorbing had flow issues, was clogged/blocked/occluded, and leaked.The following information was provided by the initial reporter: "we have had leaking from all the ports on tubing set, some sets cannot prime and another problem with a set becoming occluded after 75% of the infusion was complete.".

Event Description

It was reported gem v/nv 20dp ckv 2ss 0.2mf low sorbing had flow issues, was clogged/blocked/occluded, and leaked.The following information was provided by the initial reporter: "we have had leaking from all the ports on tubing set, some sets cannot prime and another problem with a set becoming occluded after 75% of the infusion was complete.".

Manufacturer Narrative

H6: investigation summary: two samples (model #11532269) were returned by the customer.It was reported that the sets did not prime.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were unable to be primed passed the filter.Fluid was attempted to be flushed through the smartsites, but was met with force.On one set, the pumping segment developed a small tear from fluid trying to be forced through the set.A quality notification has been sent to the supplier, and the samples have been sent for further investigation.The supplier was able to confirm the occlusions on both samples.However, the root cause of the occlusions could not be determined.One used primary set, model 11532269, was returned by the customer for investigation.The set was visually inspected, and then primed with a blue dye solution.Leaks could clearly be seen at the proximal smartsite within the set.The customer complaint can be verified.Upon further inspection, it was observed that the leaking smartsite was oval shaped instead of the expected circular shape.This caused the internal smartsite channel to remain open and easily allow fluid through which to flow.A device history record review for model 11532269 lot number 21035291 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The machine that assembles the smartsite components has sensors to detect ovality conditions.This testing is performed 100% of the process, assuring that there is no leakage of this part.Additionally, in order for the smartsite to undergo any type of plastic deformation such as the ovality condition, they must be submitted or exposed below -40f or above 125f.The manufacturing environment within the cleanroom is roughly 69f.Therefore, the manufacturing process could be discarded as a source of the leakage by ovality condition on smartsite valve parts.The oval smartsite defect was determined to be a result of the environmental process the set was subjected to after leaving the manufacturing site.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12523288
• MDR Text Key: 273106643
• Report Number: 9616066-2021-52126
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232341
• UDI-Public: 50885403232341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/04/2024
• Device Model Number: 11532269
• Device Catalogue Number: 11532269
• Device Lot Number: 21035291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1