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

Model Number 2420-0007

Device Problems Reflux within Device (1522); Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Requested patient demographics however customer decline to answer.

Event Description

The customer reported that a secondary non bd set was prepared for unspecified antibiotic infusion.The rn clamped the primary line to initiated the antibiotic however the rn noticed hat the secondary back flowed into the primary set.There was no patient harm however there was a delay in the medication in which patient required a new antibiotic and tubing set up.The event occurred in the icu.

Manufacturer Narrative

Concomitant medical products: 50ml baxter infusion bag (lot nc119924 exp 04apr20) of clindamycin in 0.9% nacl injection usp; 1000ml b braun infusion bag (lot j8n155 exp 04/21) of lactated ringers.The customer¿s report of secondary set back flowed into primary was not confirmed.Visual inspection of the set noted no damage or any anomalies.The check valve was inspected under magnification and was noted to be assembled in the set correctly, and the silicone membrane was centered.Functional testing resulted in no air bubbles or fluid going past the check valve or into the primary bag.Disassembly of the check valve resulted in normal findings.No particulates were noted on the diaphragm membrane or any solvent to the check valve component with no damages to the interior of the check valve or to the diaphragm.The root cause of this failure was not identified.

Event Description

The customer reported that a secondary non bd set was prepared for unspecified antibiotic infusion.The rn clamped the primary line to initiate the antibiotic however the rn noticed hat the secondary back flowed into the primary set.There was no patient harm however there was a delay in the medication in which patient required a new antibiotic and tubing set up.The event occurred in the icu.

• 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: 8378613
• MDR Text Key: 137426938
• Report Number: 9616066-2019-00502
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8110,B BRAUN SEC LINE, THERAPY DATE (B)(6) 2018; NON-BD SECONDARY SET; 8015,8110,B BRAUN SEC LINE, THERAPY DATE (B)(6) 2018