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

Model Number VITAL SIGNS® PRESSURE INFUSOR

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the vital signs® pressure infusor has a leaking valve.It happened during use, and the machine alarmed "o2 calibration" and "occlusion." the patient had to be sedated further in order to stop the alarm from sounding.Harm or injury is unknown.

Manufacturer Narrative

The device history record review show all units were proceeded leakage test according to work instruction and the inspection record showed the sampling inspection of manufactured lot pass all the inspection requirement on visual and packaging requirement.The mwi-51004353-as-004/a showed the assembly method was welding the pvc tube with flange with using the rf welding machine.In mwi-510043xx-as-004 rev.:b.,which effective on (b)(6) 2016, cyc was applied for bonding of tube flange and 8 inch pvc tube instead of using welding method , due to the material incompatibility contributes to the root cause of the non weld.Due to the lack of material for evaluation and application information, the actual failure analysis could not be performed.The cause of reported case is currently undetermined.

• Brand Name: VITAL SIGNS® PRESSURE INFUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• MDR Report Key: 11426662
• MDR Text Key: 238336558
• Report Number: 3004050971-2021-00015
• Device Sequence Number: 1
• Product Code: KZD
• UDI-Device Identifier: 10817357021063
• UDI-Public: (01)10817357021063(10)160193
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS® PRESSURE INFUSOR
• Device Catalogue Number: IN800048
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention