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

Model Number 10062818

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they had difficulty removing blood tubing from the picc line.There was no report of patient harm.

Manufacturer Narrative

Concomitant products: 500ml baxter infusion bag (lot y018192 exp jul17) of 0.9% sodium chloride injection usp; therapy date (b)(6) 2016.The customer¿s report of ¿difficulty removing tubing from picc¿ was not confirmed.Visual inspection found that the male luer spin collar had multiple cracks.Tool marks and stress marks were found on the male luer spike indicating difficulty with removing the set at that connection.Functional testing could not be performed due to the broken male luer.Dimensional testing on the primary set¿s male luer was determined to be within specification.The probable cause of difficulty removing the tubing from the picc line is most likely due to overtightening the male luer at that connection.

Manufacturer Narrative

This file is not reportable as the tubing was removed and the picc line remained intact.

Manufacturer Narrative

Correction/additional information: please disregard/cancel follow up 3.The failure investigation showed a crack in the tubing which is a reportable malfunction.

• 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: 5843226
• MDR Text Key: 51034797
• Report Number: 9616066-2016-01033
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/26/2016

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: 10062818
• Device Catalogue Number: 10062818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/10/2016; 09/29/2016; 02/01/2017; 02/20/2017
• 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
• Patient Age: 64 YR