MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 115332269

Device Problems Backflow (1064); Crack (1135); Fluid/Blood Leak (1250); Filtration Problem (2941)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

Narrative from staff: during initial assessment at first care time, rn examined the patient's piv site in right hand.There was an unusual amount of blood backing up into the tpn tubing, rn flushed it with about 1.5ml ns and there was no problem with the site, however the diluted blood was really backing up into the tubing and filter.I notified the charge nurse and planned to change the filter extension at the end of the tpn tubing.After examining it together they found there was a crack in the filter and tpn was leaking out there.The blanket than had just been changed was wet.Rn next notified nnp and nnp agreed with changing out the iv tubing and extension filter, which was obtained from pharmacy.It was changed without incident and there is no longer any blood backing up into the tubing.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 12975241
• MDR Text Key: 282055153
• Report Number: 12975241
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115332269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 DA
• Patient Sex: Female
• Patient Weight: 2 KG