MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MSIII HALF DEHP SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	28117E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20076951.Medical device expiration date: 2023-07-27.Device manufacture date: 2020-07-17.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the msiii half dehp ss tubing was defective and not properly seated during use.This occurred once each in lots 20076951 and an unspecified lot.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "alaris pump has been serviced but still getting an error code stating: ¿ the tubing collar is not properly seated.¿".
Event or Problem Description
It was reported that the msiii half dehp ss tubing was defective and not properly seated during use.This occurred once each in lots 20076951 and an unspecified lot.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "alaris pump has been serviced but still getting an error code stating: ¿ the tubing collar is not properly seated.¿".
Additional Manufacturer Narrative
H6: investigation summary one sample was received for failure investigation.The customer complaint of tubing defective / damaged was not verified based on testing of the infusion set with the infusion set pump.Testing was conducted with the infusions set and a ms iii pump submitted by the customer.During testing the submitted infusion set did not show any issues during priming of the sets.The pump that was submitted with the infusion set for testing, showed signs of damage and did have issues with missing parts and broken parts when evaluated.Once those issues were corrected on the pump, the infusion sets had no issues fitting onto the pump.The investigation did not yield any issues with the 28117e infusions sets themselves.A device history record review for model 28117e lot number 20076951 was performed.The search showed that a total of 5,973 units in 1 lot number was built on 27jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the investigation conducted, the testing showed that improper installation of the infusion set is the probable root cause for the issue seen in the reported complaint.

• Brand Name: MSIII HALF DEHP SS
• Common Device Name: 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: 12283405
• Report Number: 9616066-2021-51714
• Device Sequence Number: 3532002
• Product Code: FPA
• UDI-Device Identifier: 50885403274891
• UDI-Public: 50885403274891
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K874564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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
• Operator of Device: Other
• Device Model Number: 28117E
• Device Catalogue Number: 28117E
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown