MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEMINI SYRINGE VTD SET, DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10010483
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.
Event or Problem Description
It was reported that 4 gemini syringe vtd set, dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: these are the used products submitted to me by xxxxxxxx that also had air in line issues.X3 syringe set ref # (b)(4): 1 low sorb tubing with 0.2 micron filter ref # (b)(4): 1 syringe set (infusing il) ref # (b)(4): 1 blue filter with 1.2 micron filter attached to the prior syringe.1 smartsite triple connector ref # (b)(4).
Event or Problem Description
It was reported that 4 gemini syringe vtd set, dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: these are the used products submitted to me by xxxxxxxx that also had air in line issues.X3 syringe set ref # (b)(4): 1 low sorb tubing with 0.2 micron filter ref # (b)(4): 1 syringe set (infusing il) ref # (b)(4) : 1 blue filter with 1.2 micron filter attached to the prior syringe.1 smartsite triple connector ref # (b)(4).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09/29/2020.Investigation conclusion: three samples were returned by the customer.Two of the samples were analyzed for defects and primed.No defects were found.The failure was unable to be replicated.However, the third sample was unable to be primed.Upon examination, there appeared to be small leaks at the upper pump segment connection, possibly causing air to enter the line.No damage/tears in the segment could be identified.A device history record review could not be performed on model 10010483 because a lot number was not provided by the customer.A root cause could not be determined for air in line in two of the samples because the failure could not be replicated.A root cause for air in line in the third sample can most likely be attributed to small leaks at the upper pump segment connection, possibly causing air to enter the line.A root cause for the small leaks at the upper pump segment connection could not be identified.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: GEMINI SYRINGE VTD SET, DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10603115
• Report Number: 9616066-2020-02887
• Device Sequence Number: 14365052
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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 Catalogue Number: 10010483
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other