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

Model Number 2426-0007

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report that two pumping segments ballooned was not confirmed.The 2 used suspect primary sets that were in use at the time of the customer event were not returned for investigation.Received were 742 unused packaged associate sets with the following lot numbers: 19046410 (suspect lot number), 19046194, 19065143, 19056955, 19046440, and 19046734.Functional testing of a random sample of the returned sets did not replicate the bulge/balloon in the silicone segment of the tubing.Pressure testing also found no anomalies with the returned sets.The probable cause identified from previous extensive failure investigations have found that bulge/balloon could occur when an iv push medication or flush was executed below the pump without clamping the tubing above the injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to balloon.The root cause of the customer¿s experience was not identified because no balloons were replicated during functional testing.

Event Description

It was reported that during an unspecified infusion, the pumping segment ballooned.A second tubing was obtained and that pumping segment ballooned as well.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8967154
• MDR Text Key: 156881435
• Report Number: 9616066-2019-02466
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19046410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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