MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; PREMIERPRO 1000ML PRESSURE INFUSION BAG, MESH BACK

Model Number 8808

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

The pressure bag leaking pressure could delay or interrupt therapy.This is attached to an arterial line and can impact patient therapy.The patient was impacted due to respiratory distress.

Event Description

Customer believes air could be located within the lines during use. 1 - child: tachycardic, respiratory distress for short time, scan did not confirm air embolism 1 - adult: tachycardic, respiratory distress for short time, scan did not confirm air embolism.

Manufacturer Narrative

The pressure bag leaking pressure could delay or interrupt therapy.This is attached to an arterial line and can impact patient therapy.The patient was impacted due to respiratory distress summary: investigation to reported defect identifies that air in the fluid lines could not be caused by pib device.Air in the pib does not enter fluid bag/fluid lines.Image of device was shared with customer and investigation form completed and returned to customer.Ra: product design does not constitute any additional risk not taken into account by rma-20012a, risk id r15 - rapid infusion may cause iv bag to burst.

Event Description

Customer believes air could be located within the lines during use. child: tachycardic, respiratory distress for short time, scan did not confirm air embolism: adult: tachycardic, respiratory distress for short time, scan did not confirm air embolism.

• Brand Name: SUNMED LLC
• Type of Device: PREMIERPRO 1000ML PRESSURE INFUSION BAG, MESH BACK
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand ledge MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand ledge MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16523210
• MDR Text Key: 311089112
• Report Number: 1314417-2023-00006
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8808
• Device Catalogue Number: 8808
• Device Lot Number: 220800630
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2023
• 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): Other