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

Model Number	2429-0500
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that during a levophed infusion that the pump alarmed "occlusion".The nurse discovered that the silicone segment was occluded, sealing the sides of the tubing together which inhibited the correct flow of medication to the patient.The patient¿s blood pressure dropped and the levophed drip was increased to support the patient's blood pressure.There was no permanent harm.
Additional Manufacturer Narrative
The customer¿s report that the silicone segment was occluded, sealing the sides of the tubing together was confirmed.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, kinks, holes, and tears in the tubing and its components.Visual inspection observed two fused sections in the silicone tubing.The first fused section was approximately 2 inches below the upper fitment.The second fused section was approximately 1.75 inches above the lower fitment.With the set loaded in a test lab pump module, the both fused sections lined up with the pump module¿s upper and lower occluder.There were no other anomalies noted with the received set.Functional testing was performed.Fluid did not fill the drip chamber and did not flow through set.The fused sections of silicone tubing were massaged per suggestions from the chamber blocked tip sheet until they were no longer fused.Fluid was then observed to be able to flow through the set.The sets were then loaded into a lab pump module.The infusion completed with no anomalies observed.After the infusion was completed the set was left in the pump module for 4 hours.The set was removed from the pump module and did not observe any issues.Dimensional testing was performed on the silicone segment tubing.The tubing thickness measured within specification(s).The overall tubing shape was observed to be concentric.The root cause of the this failure was not identified, however is likely due to the type of medication that was used in the set; as well as the set being loaded in a device while off for an extended period of time under fixed compression.
Event or Problem Description
It was reported that during a levophed infusion that the pump alarmed "occlusion".The nurse discovered that the silicone segment was occluded, sealing the sides of the tubing together which inhibited the correct flow of medication to the patient.The patient¿s blood pressure dropped and the levophed drip was increased to support the patient's blood pressure.There was no permanent harm.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9831810
• Report Number: 9616066-2020-00771
• Device Sequence Number: 2421334
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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 Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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: 8100, 8015, CUROS CAPS,TD (B)(6) 2020
• Outcome Attributed to Adverse Event: Required Intervention