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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Type  malfunction  

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.Although requested, no additional information, (including patient information), has been received.

Event Description

It was reported that the nurse was unable to flush the line, and then the pump segment ballooned.

Manufacturer Narrative

The customer¿s report that the pump segment ballooned was confirmed.Visual inspection of the set noted that the silicone segment tubing had a bulge (.8065 inches long,.4980 inches wide), discoloration, and was weakened just below the upper fitment.Clear liquid was observed inside both of the set¿s tubing and drip chambers.No other anomalies were observed.Functional testing resulted in liquid flowing freely with no issues observed.The set was loaded into a lab pump module device.The primary infusion was programmed at a rate of 120ml/h and vtbi 120ml for 1 hour.No alarms or any other issues were noted by the device.No bulge/ balloon was observed in the silicone segment.The set was attached to an air pump and completely submerged in warm water.A balloon appeared.The root cause for the source of the excessive pressure was not determined.The customer¿s report that the nurse was unable to flush was not confirmed.Functional testing was performed and the set was able to flush.

Event Description

It was reported that the nurse was unable to flush and then the pump segment ballooned.

• 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: 8871102
• MDR Text Key: 153585408
• Report Number: 9616066-2019-02201
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• 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: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1