MAUDE Adverse Event Report: VYAIRE MEDICAL IN900012 INFUSO PRESSURE (SERUM RUSH) 1000 ML; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	IN900012 INFUSO PRESSURE (SERUM RUSH) 1000 ML
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, the root cause has not been determined yet.
Event or Problem Description
It was reported to vyaire medical that in900012 infuso pressure (serum rush) 1000 ml lose pressure during the operation of the device.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: IN900012 INFUSO PRESSURE (SERUM RUSH) 1000 ML
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11368837
• Report Number: 3004050971-2021-00014
• Device Sequence Number: 19053414
• Product Code: KZD
• UDI-Device Identifier: 07613327500110
• UDI-Public: (01)07613327500110(10)175086
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: IN900012 INFUSO PRESSURE (SERUM RUSH) 1000 ML
• Device Catalogue Number: IN900012
• Device Lot Number: 175086 AND 180371
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1