MAUDE Adverse Event Report: CAREFUSION MAXGUARD TRI-FUSE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME1021
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set will not be returned by the customer for investigation.The root cause of this failure could not be identified.Information on patient name, age, and weight was not provided on the received medwatch from an unknown initial reporter.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report which states, "the rn was in the patient room next to the patient's bed.The patient sat in his mom's lap on the patient bed and it was at this time that this rn noticed that the tpn tubing had become disconnected from the patient's picc trifuse and was lying on the bed.This rn clamped the trifuse, paused the tpn, and notified the charge nurse and the provider.The provider told this rn that he/she would order fluids to replace the tpn.The patient was sitting calmly with mom m the chair.This rn lifted up the remaining tubing with lipids running noticed that the lipid tubing had just been disconnected from the trifuse as well.This rn notified the provider and the charge nurse.Patient later developed clabsi and is being treated.However, we have not identified a confirmed link between the clabsi and the trifuse tubing.The rn was able to easily pull apart the tnfuse tubing.She grasped the clear hub and the other end of the tubing where it branches into the three stems and with a little bit of force, was able to pull it apart.The tubing itself does not tear apart or stretch.Instead, the tubing pulls away from where it inserts into the clear hub.If the tubing were connected to a patient, the clear hub would remain screwed to the patient's line adapter and the tubing of the tnfuse would be separated from it." an incomplete date of event of (b)(6) 2020 was provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report which states, "the rn was in the patient room next to the patient's bed.The patient sat in his mom's lap on the patient bed and it was at this time that this rn noticed that the tpn tubing had become disconnected from the patient's picc trifuse and was lying on the bed.This rn clamped the trifuse, paused the tpn, and notified the charge nurse and the provider.The provider told this rn that he/she would order fluids to replace the tpn.The patient was sitting calmly with mom m the chair.This rn lifted up the remaining tubing with lipids running noticed that the lipid tubing had 3ust been disconnected from the trifuse as well.This rn notified the provider and the charge nurse.Patient later developed clabsi and is being treated.However, we have not identified a confirmed link between the clabsi and the trifuse tubing.The rn was able to easily pull apart the tnfuse tubing.She grasped the clear hub and the other end of the tubing where it branches into the three stems and with a little bit of force, was able to pull it apart.The tubing itself does not tear apart or stretch.Instead, the tubing pulls away from where it inserts into the clear hub.If the tubing were connected to a patient, the clear hub would remain screwed to the patient's line adapter and the tubing of the tnfuse would be separated from it." an incomplete date of event on (b)(6) 2020 was provided.

• Brand Name: MAXGUARD TRI-FUSE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9967463
• Report Number: 9616066-2020-01353
• Device Sequence Number: 14282502
• Product Code: FPA
• UDI-Device Identifier: 10885403235955
• UDI-Public: 10885403235955
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2024
• Device Model Number: ME1021
• Device Catalogue Number: ME1021
• Device Lot Number: 19106405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (2)8100,8015,(2)PRI TUBING, TD XX-FEB-2020
• Outcome Attributed to Adverse Event: Required Intervention