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

Model Number 2426-0007

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported that last weekend, tubing leaked from a hole that developed above the section that inserts into the pump module during patient use.There was no patient harm.

Manufacturer Narrative

The customer¿s report of the set leaking was confirmed and replicated; however, the leak was below the lower fitment, not above the upper fitment as reported.Visual inspection showed that the vinyl tubing had a 0.0346 inch long slice cut approximately 11 1/2 inches below the lower fitment.Functional and pressure testing was performed and a leak was observed from the cut below the lower fitment.The cause of the leak was a cut in the tubing.The slice cut is consistent with damage of a box cutter being used to open the package or a sharp object being used at some point during infusion to remove tape from the tubing.

Event Description

The customer reported that last weekend, tubing leaked from a hole that developed above the section that inserts into the pump module during patient use.There was no patient harm.

• 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
• MDR Report Key: 7860740
• MDR Text Key: 119806764
• Report Number: 9616066-2018-01556
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE UNK