MAUDE Adverse Event Report: SUNMED LLC SUNMED LLC; NOVAPLUS 500ML PRESSURE INFUSION BAG

Model Number V4005H

Device Problem Leak/Splash (1354)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

The pressure bag leaking pressure could delay or interrupt therapy, as the clinician needed to re-inflate numerous times.This is attached to an arterial line and can impact patient therapy.

Event Description

Bag did not maintain pressure. .

Manufacturer Narrative

The pressure bag leaking pressure could delay or interrupt therapy, as the clinician needed to re-inflate numerous times.This is attached to an arterial line and can impact patient therapy.The defect of leakage was confirmed for the pressure infusion bag.A small cut was observed near the seam of the bag.No additional indicators were found to identify where the defect occurred, the defect may be a result of the manufacturing process or handling.Rma-20012c has been reviewed for risk associated with the observed defect.Damage to the peep bag has been included and assessed for risk on lines r19 and r9 these have a severity of 6 and occurrence of 3 and 5 respectively.

Event Description

Bag did not maintain pressure. .

• Brand Name: SUNMED LLC
• Type of Device: NOVAPLUS 500ML PRESSURE INFUSION BAG
• Manufacturer (Section D): SUNMED LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17914339
• MDR Text Key: 325503126
• Report Number: 1314417-2023-00022
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V4005H
• Device Catalogue Number: V4005H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other