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

Model Number 2420-0007

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient's demographics were not provided.

Event Description

It was reported that there was a bulge in the iv tubing set during an infusion of a continuous unspecified fluid at a rate of 125ml for 1 hour.The pump module beep occluded, the rn disconnected the iv tubing and found the line to be sluggish.There was no patient impact.

Manufacturer Narrative

Created to change the status of file from malfunction to serious injury-additional.

Event Description

It was reported that there was a bulge in the iv tubing set during an infusion of a continuous unspecified fluid at a rate of 125ml for 1 hour.The pump module beep occluded, the nurse disconnected the iv tubing, and found the line to be sluggish.It was further confirmed during follow up, that there was no patient harm, however; the patient received tpa to clear the line.

Manufacturer Narrative

Additional information added; h.6.(device code) the report of ballooning in the silicone segment was confirmed by visual inspection.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing, or damage to the components.Visual inspection confirmed a balloon in the silicone tubing pump segment in-between the upper and lower fitment.The balloon was visually observed to be directly below the upper fitment.No other anomalies or evidence of damage were observed upon visual inspection the silicone tubing segment was cut precisely one inch below the balloon and inspected under magnification; the walls were found to be concentric.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that there was a bulge in the iv tubing set during an infusion of a continuous unspecified fluid at a rate of 125ml for 1 hour.The pump module beep occluded, the nurse disconnected the iv tubing, and found the line to be sluggish.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9758612
• MDR Text Key: 191694477
• Report Number: 9616066-2020-00568
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/03/2020; 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE
• Patient Outcome(s): Other
• Patient Weight: 81