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

Model Number 2429-0500

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

The customer reported that the tubing set cracked and leaked at the silicone pump segment during a 0.9% nacl infusion.The customer further states that there was no ballooning observed in the tubing, nor was there any type of iv push or line access prior to the event.There was no patient harm.

Event Description

The customer reported that the nurse primed the tubing set with normal saline 500ml bag and placed it into the pump and began the infusion.The patient's daughter called the nurse to the room as she noted that fluid was dripping form the bottom of the pump.Upon assessment it was found that the tubing set had cracked and leaked at the upper fitment of the silicone pump segment.The customer further states that there was no ballooning observed in the tubing, nor was there any type of iv push or line access prior to the event.There was no patient harm.

Manufacturer Narrative

The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

The customer reported that the nurse primed the tubing set with a normal saline 500ml bag and placed it into the pump and began the infusion.The patient's daughter called the nurse to the room as she noted that fluid was dripping from the bottom of the pump.Upon assessment it was found that the tubing set had cracked and leaked at the upper fitment of the silicone pump segment.The customer further states that there was no ballooning observed in the tubing, nor was there any type of iv push or line access prior to the event.There was no patient harm.

Manufacturer Narrative

The customer¿s report that the tubing cracked and leaked at the pump segment was confirmed.During visual inspection of the set it was observed that the silicone segment had a tear near the upper fitment.Functional testing resulted in a leak from the tear.The root cause of the customer's report could not be determined.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVSCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7904209
• MDR Text Key: 121564973
• Report Number: 9616066-2018-01792
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• 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,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 18085166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, TD (B)(6) 2018