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

Model Number PRI TUBING

Device Problems Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

The customer complaint of balloon in the silicone segment was confirmed in the photo received from the customer; the photo shows that the silicone segment tubing had a ballooned bulge at the upper portion near the upper fitment.However, no product will be returned; the product was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that a patient had tpn and il infusing when the lipids had to be stopped because the pump kept alarming "occlusion." the nurse removed the tubing from the pump and noted that there was an enlarged "bubble" in the part of the tubing that is inserted in the pump.There was no report of patient harm, however the nurse stated the patient's broviac catheter broke later that day requiring it to be repaired.

• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5988711
• MDR Text Key: 55986512
• Report Number: 9616066-2016-01302
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 8100,8015
• Patient Outcome(s): Other
• Patient Age: 2 YR