MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number 2420-0500

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 10/05/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of a few slits in the tubing sets upon opening the packages was confirmed on both primary sets model 2420-0500.No damage was observed on primary set model 2426-0500.The sets were visually inspected.No damage was noted in any of the packaging, or the iv bags that were returned.A horizontal slit/cut on the tubing measuring approximately 0.1180 inches long was observed two inches below the proximal smartsite on model 2420-0500 lot 19085738 iv set.Also a horizontal slit/cut on the tubing measuring approximately 0.1480 inches long was observed fifteen inches above the male luer on model 2420-0500, lot unknown iv set.There was no slit identified on the 2426-0500, lot unknown tubing.Functional and pressure testing was performed, leaking was observed in the same location as the slits of both the 2420-0500 tubing sets.No leaking was observed on set model 2426-0500 tubing or components.The root cause of the slit/cut in the sleeve tubing was not definitively determined.The customer¿s later report that the slits were in the iv bags or pouches and not the tubing sets was not confirmed.

Event Description

It was reported that the user noticed a few slits in the tubing sets upon opening the packages however it was later reported and confirmed that the slits were in the bags, and not the tubing sets.Although multiple attempts were made; the customer has no other additional event details and requested to close the complaint.The tubing sets were received with iv bags medication label documents meropenem (1000mg/100ml) rate 100ml/hr over 3 hrs., and dopamine hcl 800mg/250ml.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9705199
• MDR Text Key: 199291476
• Report Number: 9616066-2020-00487
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 64 YR