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

Model Number 2426-0007

Device Problems Stretched (1601); Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 12/04/2019

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

It was reported that the set has a balloon in the silicone segment.It was observed to be a "bleb" in the pump segment.Per the reporter, the patient's antibiotic treatment was delayed "7 hours." although requested, no additional patient information was provided.

Manufacturer Narrative

The customer¿s report of the set has a balloon in the silicone segment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.During inspection it was observed that the silicone segment tubing had a balloon, discoloration, and was weakened just below the upper fitment.Yellowish/brown liquid was observed inside the entire length of the set¿s tubing and drip chamber.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.No other abnormalities were observed on the set during visual inspection.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 the set has a "balloon", in the silicone segment.It was observed to be a "bleb" in the pump segment.Per the reporter, the patient's antibiotic treatment was delayed "7 hours." although requested, there has been no impact to patient response or additional event information made available to date.

• 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: 9644949
• MDR Text Key: 179440159
• Report Number: 9616066-2020-00233
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 ALCOHOL CAP, THERAPY DATE (B)(6) 2019