MAUDE Adverse Event Report: AS LVP HALF SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	2403-0007
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used.Medical 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 as lvp half ss had air bubbles in the line while infusing blinatumomab.The following information was provided by the initial reporter: "rn called unit qi nurse and educator into pt room due to pump alarming " air in line".Pt was infusing blinatumomab throughout curlin tubing connected to an alaris 1/2 set.Per rn, pump had been beeping frequently since last evening.On inspection of the tubing, a few bubbles were seen below the alaris pump and one small one above.No air was noticed in the curlin tubing.When the "restart" button was pushed the infusion would continue to infuse (without the beep for a while).The physician was notified and pt to be moved to the curlin home pump once discharge was confirmed.".
Additional Manufacturer Narrative
Investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed, and then infused with the pump dchu-0009 and pump module dchu-0015 at 125 ml / hr.No air bubbles were observed in the tubing.The customer complaint that there were bubbles in the tubing and the pump was alarming could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the as lvp half ss had air bubbles in the line while infusing blinatumomab.The following information was provided by the initial reporter: "rn called unit qi nurse and educator into pt room due to pump alarming " air in line".Pt was infusing blinatumomab throught curlin tubing connected to an alaris 1/2 set.Per rn, pump had been beeping frequently since last evening.On inspection of the tubing, a few bubbles were seen below the alaris pump and one small one above.No air was noticed in the curlin tubing.When the "restart" button was pushed the infusion would continue to infuse (without the beep for a while).The physician was notified and pt to be moved to the curlin home pump once discharge was confirmed.".

• Brand Name: AS LVP HALF SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12139690
• Report Number: 9616066-2021-51486
• Device Sequence Number: 3801008
• Product Code: FPA
• UDI-Device Identifier: 50885403232471
• UDI-Public: 50885403232471
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 08/31/2021

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: 2403-0007
• Device Catalogue Number: 2403-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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 Age: 12 YR