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

Model Number 11522558

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

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

It was reported that the patient's iv pump was alarming for occlusion at patient side.The iv was flushed without problem.Upon investigation it was found that the tubing that is inside the pump had a large bulging defect in it.

Event Description

It was reported that the patient's iv pump was alarming for occlusion on the patient side.The iv was flushed without problem.Upon further investigation, it was found that the tubing that is inside the pump had a large "bulging" defect in it.Although it was reported that patient care was delayed, it did not contribute to, or result in serious adverse impact to the patient.

Manufacturer Narrative

The customer¿s report that the patient's iv pump was alarming for an occlusion not was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed within the tubing throughout the set.The customer also reported that the tubing had a large bulging defect was confirmed.At the top of the silicone pump segment tubing near the upper fitment, a balloon was observed.Functional testing was performed.The primary infusion completed with no alarms or issues.The root cause of the customer¿s experience was not identified.

• 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: 9498556
• MDR Text Key: 177015686
• Report Number: 9616066-2019-03713
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE: (B)(6)2019