MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. TRI-PORT EXT W/3 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20038E
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the tri port ext w3 vlv ports experienced air bubbles air in line.The following information was provided by the initial reporter: it was noticed at the beginning of the shift that the air filter on the tpn tubing had de-primed product reference number (b)(4).The line was disconnected from the ecmo manifold and de aired by a line team member assigned to a patient in the pod.This occurred twice.Shortly after 2000 micro-bubbles were noted in the distal 3 way stopcock located in line between the manifold and the ecmo pigtail.The stopcock was changed, air was then noted in the manifold, it was changed.At approx.2030 i came to the bedside where all lines and filters were re-examined.All lines were disconnected individually and de-aired and reattached, new intra lipids were hung with new air filter product reference number (b)(4).Within 5 minutes the tpn air filter had filled with air, the line was rehung with a separate air filter product reference number(b)(4) and rehung.Shortly after all air filters in line # (b)(4) had filled with air, micro-bubbles were noted again in the 3-way stopcock.All filters were removed from the lines and lines were connected to individual ports on the manifold, thus removing a 3-way line splitter from the troubleshooting.At 2200 ecmoo manager on call was notified of the issue and current fix.At 0245 micro-bubbles were noted at the 3 way stopcock again it was changed again.Air was noted in iv lines post alaris pump infusion chamber.Alaris pump brain and all 4 modules were changed lines were de-aired again filters were added back into line to see if alaris change made a difference.Within 5 minutes all air filters had refilled with air.During the entire shift all troubleshooting ecmo pump venous pressure ranged between 30 and 35, pre and post pressure were 270-290 and 256-273 respectively.All troubleshooting was completed, inspected, and double checked by the nicu bedside nurse, the ecmo bedside specialist, a member of line team, and the in house ecmo primer without resolution for the filters filling with air.Filters de-aired regardless of being held above, below, or equal to the level of the manifold.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 09/29/2020 investigation conclusion the customer's report of that shortly after all air filters in line filled with air, micro-bubbles were noted again in the 3-way stopcock was not confirmed based on the customer provided sample.The sample showed an absence of air in the line when fully primed.A sample has been received and the root cause could not be identified as the issue was not confirmed.A device history record review could not be performed on model 20038e because a lot number was not provided by the customer.
Event or Problem Description
It was reported that the tri-port ext w/3 vlv ports experienced air bubbles/air in line.The following information was provided by the initial reporter: it was noticed at the beginning of the shift that the air filter on the tpn tubing had de-primed (product reference number 2432-0007).The line was disconnected from the ecmo manifold and de-aired by a line team member assigned to a patient in the pod.This occurred twice.Shortly after 2000 micro-bubbles were noted in the distal 3-way stopcock located in line between the manifold and the ecmo pigtail.The stopcock was changed, air was then noted in the manifold, it was changed.At approx.2030 i came to the bedside where all lines and filters were re-examined.All lines were disconnected individually and de-aired and reattached, new intra lipids were hung with new air filter (product reference4 number 20129e).Within 5 minutes the tpn air filter had filled with air, the line was rehung with a separate air filter (product reference number 10011865) and rehung.Shortly after all air filters in line (# 20129e and 10011865) had filled with air, micro-bubbles were noted again in the 3-way stopcock.All filters were removed from the lines and lines were connected to individual ports on the manifold, thus removing a 3-way line splitter from the troubleshooting.At 2200 ecmoo manager on call was notified of the issue and current fix.At 0245 micro-bubbles were noted at the 3-way stopcock again it was changed again.Air was noted in iv lines post alaris pump infusion chamber.Alaris pump brain and all 4 modules were changed lines were de-aired again filters were added back into line to see if alaris change made a difference.Within 5 minutes all air filters had refilled with air.During the entire shift all troubleshooting ecmo pump venous pressure ranged between 30 and 35, pre and post pressure were 270-290 and 256-273 respectively.All troubleshooting was completed, inspected, and double checked by the nicu bedside nurse, the ecmo bedside specialist, a member of line team, and the in house ecmo primer without resolution for the filters filling with air.Filters de-aired regardless of being held above, below, or equal to the level of the manifold.

• Brand Name: TRI-PORT EXT W/3 VLV PORTS
• 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: 10538609
• Report Number: 9616066-2020-02783
• Device Sequence Number: 14154024
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: 07613203011976
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 08/26/2020

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: 20038E
• 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: 09/15/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015,; 8100,8015,
• Outcome Attributed to Adverse Event: Other