MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics were not provided.

Event Description

It was reported that the tubing ballooned.The nurse stated that while infusing, she found the blue part was not sitting in the chamber but on top of the chamber causing the bubble to form.The tubing was also kinked, causing the pump to continue to alarm for occlusion on the patient side.Although requested, no additional event and/or patient information was provided.

Manufacturer Narrative

Additional information added; section; b.5.(patient information clarified/detailed).The customer¿s complaint of a tubing balloon was confirmed per photo received by the customer.However, no kinks were observed on the tubing as reported by the customer per provided photo.A photo provided by the customer shows a bulge/balloon in the silicone segment tubing near the upper fitment.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that the tubing ballooned.The nurse stated that while infusing, she found the blue part was not sitting in the chamber but on top of the chamber causing the bubble to form.The tubing was also kinked, causing the pump to continue to alarm for occlusion on the patient side.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: PRIMARY TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9913495
• MDR Text Key: 190314687
• Report Number: 9616066-2020-01115
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2020.