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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/16/2019

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.The event did not occur during patient use.

Event Description

Received a copy of the customer's sus voluntary event report from fda which states, "pt tubing was being set up and tubing primed when tubing primed, tubing ballooned out tubing was not used on the pt.".

Manufacturer Narrative

The customer¿s report that the tubing ballooned was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed inside the tubing throughout the entire set.At the top of the silicone pump segment tubing near the upper fitment, a balloon was observed.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

Received a copy of the customer's sus voluntary event report from fda which states, "pt tubing was being set up and tubing primed when tubing primed, tubing ballooned out tubing was not used on the pt.".

Event Description

Received a copy of the customer's sus voluntary event report from fda which states, "pt tubing was being set up and tubing primed when tubing primed, tubing ballooned out tubing was not used on the pt.".

Manufacturer Narrative

Additional information added in section concomitant medical products.

• 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: 9275159
• MDR Text Key: 167364467
• Report Number: 9616066-2019-03125
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19073075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1000ML BAXTER BAG, THERAPY DATE 09/16/2019.