MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	VITAL SIGNS® PRESSURE INFUSOR
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the 500ml pressure infusor bag mfg item # in800048 lost pressure more quickly than normal.This issue occurred while connected to a patient and there was no harm reported.
Additional Manufacturer Narrative
Result of investigation: no sample was returned for evaluation.The structure review was made for the complaint pvc tubing and stopcock.And according to the work instruction mwi-51004353-as-008/g, the pvc tubing and stopcock were assembled without glue, the pvc tubing maybe deformed which can cause the pvc tubing and stopcock to have air leakage.This issue was traced to the product design, and as a corrective and preventive action, the scn 101216 was submitted to vyaire for adding cyc for the bonding of pvc tube and stopcock.The infusor product label for specific shelf time requirements was updated as well.

• Brand Name: VITAL SIGNS PRESSURE INFUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11771853
• Report Number: 3004050971-2021-00019
• Device Sequence Number: 3778603
• Product Code: KZD
• UDI-Device Identifier: 10817357021063
• UDI-Public: (01)10817357021063
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: Health Professional
• Device Model Number: VITAL SIGNS® PRESSURE INFUSOR
• Device Catalogue Number: IN800048
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1