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	04/06/2021
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 (b)(4) vital signs® pressure infusor experienced pressure issue.It can only hold pressure at 300mmhg for about 20 mins.As of this time, there is no information regarding patient harm with this reported event.
Additional Manufacturer Narrative
Result of investigation: only a photos received by the supplier for investigation.Lot number information 64-43831 is not the number format for infusor product.The investigation team reviewed the photo and the leakage location cannot be identified.Since the actual sample is not available for failure analysis, so the root cause refer to the similar complaint (b)(4).The pcv tubing and stopcock was assembled without glue.The pcv tubing may be deformed if the pcv tubing over the shelf time which can cause the pcv tubing and stopcock loose and cause leakage.Therefore, the root cause cannot be determined.
Additional Manufacturer Narrative
Device evaluation: d9, g3, g6, h2, h3, h6, and h10.The return in900012 vital signs® pressure infusor were leak tested and determined that the pvc tubing and stopcock was assembled without glue, the pvc tubing maybe deform if the pvc tubing over shelf time.

• 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
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11754222
• Report Number: 3004050971-2021-00018
• Device Sequence Number: 4138769
• Product Code: KZD
• UDI-Device Identifier: 10817357021605
• UDI-Public: (01)10817357021605
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: IN900012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 04/04/2022
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/23/2021; 04/25/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown