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

Model Number PRI TUBING

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

During a recent site visit: it was reported that the nurses had issue with tpn and occlusion alarms.The customer stated: "pharmacy would prepare the tpn infusions, a rubber band would be used to wrap up the iv set.This would cause the iv tubing to be crimped and would cause occlusion alarms.The customer performed a visual inspection found that the rubber band was too tight and would cause crimping to the line, no further issues were reported when the issues was corrected by loosening the rubber band".Although patient impact was requested it was not provided.

Manufacturer Narrative

Additional information, updated sections b.5, h.10, g.3.Patient demographics requested but not provided, however the event occurred in the pediatric cvicu, therefore it is presumed that the patient was a pediatric patient.Section b.3 requested but not provided.

Event Description

It was reported during a recent site visit : it was reported that the nurses had issue with tpn and occlusion alarms.The customer stated pharmacy would prepare the tpn infusions, a rubber band would be used to wrap up the iv set.This would cause the iv tubing to be crimped and would cause occlusion alarms.The customer performed a visual inspection found that the rubber band was too tight and would cause crimping to the line, no further issues were reported when the issues was corrected by loosening the rubber band.Although many attempts made there was no additional event details or patient impact provided at this time.The event occurred in pediatric cvicu.It was later reported that customer requested to close the complaint without any further information provided.

• 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: 9350446
• MDR Text Key: 188701954
• Report Number: 9616066-2019-03396
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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: 8015,8100