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

Model Number 2426-0500

Device Problem Stretched (1601)

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

Event Date 08/03/2018

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 the set had a bulge in the pump segment when used with the pump module. The customer tried "reworking" the set, but the bulge did not dissipate. There was no report of patient harm.

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.

Event Description

The customer reported that in pediatric hematology/oncology, the set had a bulge in the pump segment when used with the pump module. The customer tried "reworking" the set, but the bulge did not dissipate. There was no report of patient harm.

Manufacturer Narrative

Initial visual inspection observed no obvious bulging. Attached to its topmost smartsite port (located above the silicone segment) was a used bd 10ml syringe (approximately 5ml remaining). The pump segment in the area directly below the upper fitment component was observed to be more pliable when compared to the rest of the silicone segment. Priming of the set was not able to replicate a bulge. Functional testing confirmed a bulge directly below the upper fitment component when performing a test infusion. Using the remaining fluid within the attached syringe, the fluid was pushed through; the silicone segment area directly below the upper fitment component and the tubing had a bulge. The bulge was manually cleared and the test infusion resumed. When the returned syringe was attached to the smartsite port located below the silicone segment, applying the roller clamp above this port, and pushing the fluid through, there was no bulging. The root cause was not identified.

Event Description

The customer reported that in pediatric hematology/oncology, the set had a bulge in the pump segment when used with the pump module. The customer tried "reworking" the set, but the bulge did not dissipate. There was no report of patient harm.

• 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: 7810178
• MDR Text Key: 118029869
• Report Number: 9616066-2018-01457
• Device Sequence Number: 1
• Product Code: FPA
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 08/23/2018 Patient Sequence Number: 1

Treatment

8015,8100, THERAPY DATE UNK; BD 10ML SYRINGE 0.9% NACL, TD (B)(6) 2018; 8015,8100, THERAPY DATE UNK