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

Model Number	10011301
Medical Device Problem Codes	Obstruction of Flow (2423); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 100 ml hospira, ndc (b)(4), 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULA
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8499935
• Report Number: 9616066-2019-00917
• Device Sequence Number: 16812285
• Product Code: FPA
• UDI-Device Identifier: 10885403232541
• UDI-Public: 10885403232541
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE (B)(6) 2019
• Outcome Attributed to Adverse Event: Required Intervention