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

Model Number 2110-0500

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

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

The customer reported that after 1 min of infusing solumedrol, the user observed drops dripping from the pump module.The user opened the door and noted fluid squirting out of tubing.No patient harm was reported.

Manufacturer Narrative

The customer¿s report of leaking at the top of the silicone segment was confirmed.Visual inspection of the set showed that the silicone segment had a tear near the upper fitment measuring 0.0368 inches long.Examination under magnification showed no crush marks to the upper fitment.Functional and pressure testing was performed and a leak from the silicone tubing near the upper fitment was observed.The root cause of the leak was a tear in the silicone segment.The cause of the tear was not identified.

Event Description

The customer reported that after 1 min of infusing solumedrol, the user observed drops dripping from the pump module.The user opened the door and noted fluid squirting out of tubing.No patient harm was reported.

• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7515699
• MDR Text Key: 108564387
• Report Number: 9616066-2018-00589
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110-0500
• Device Catalogue Number: 2110-0500
• Other Device ID Number: 7613203012713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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