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

Model Number 10011301

Device Problems Obstruction of Flow (2423); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products- 100 ml hospira ndc 0409-7984-3,7 lot: 95-110-jt, exp: 1 nov 2020, 0.9% sodium chloride injection.Report source-effectiveness manager.The customer¿s report of occlusion was confirmed and replicated on both returned primary sets.No abnormalities were noted upon visual inspection.Functional testing observed that the fluid would not flow through the sets during priming.Microscopic inspection of the engagement between the check valve inlet port and the tubing (attached by pvc tubing, p/n 660134) identified an obstruction caused by excessive solvent; which created the inability to prime the sets.The reported issue of inability to prime was identified as an occlusion at the engagement between the set¿s check valve p/n: 630110 inlet port and tubing p/n: 605962-000.The root cause for the occlusion was excessive solvent applied during the manufacturing process.

Event Description

It was reported that when the nurse attempted to prime two pcea sets with normal saline on the same patient in the pacu, an occlusion was noted on both lines.The patient developed increased pain and required an unspecified dose of iv dilaudid due to the occlusions and delay of therapy.The clinician obtained a 3rd pcea set which primed without difficulty.

• Brand Name: ALARIS INFUSION 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8499574
• MDR Text Key: 141466299
• Report Number: 9616066-2019-00918
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232541
• UDI-Public: 10885403232541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: 10011301
• Device Catalogue Number: 10011301
• Device Lot Number: 17105892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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
• Treatment: THERAPY DATE: (B)(6) 2019
• Patient Outcome(s): Required Intervention