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

Model Number	11609481
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that the pump was alarming air in line while infusing d12.5/tpn to a neonate patient in the nicu.The infusion was stopped, clamped with the slide clamp and the tubing was removed from the pump.The rn flicked the air from its location to displace it upward and the tubing became separated at the top of the silicone segment.A minimal amount of tpn was lost since the tubing was clamped.A replacement was used with no further issues.There was no harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing became separated at the top of the silicone segment was confirmed.Visual inspection confirmed that the separation occured between the silicone pump segment tubing and the upper fitment.The upper fitment's male end was measured and was within specifications.The ring retainer was not returned for investigation.Functional testing could not be performed due to the silicone segment separation.The root cause of the separation could not be determined.
Event or Problem Description
The customer reported that the pump was alarming air in line while infusing d12.5/tpn to a neonate patient in the nicu.The infusion was stopped, clamped with the slide clamp and the tubing was removed from the pump.The rn flicked the air from its location to displace it upward and the tubing became separated at the top of the silicone segment.A minimal amount of tpn was lost since the tubing was clamped.A replacement was used with no further issues.There was no 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: 8633022
• Report Number: 9616066-2019-01410
• Device Sequence Number: 13864113
• Product Code: FPA
• UDI-Device Identifier: 10885403232596
• UDI-Public: 10885403232596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 11609481
• Device Catalogue Number: 11609481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 8100,8015,THERAPY DATE UNK; CUROS CAP; 8100,8015,THERAPY DATE UNK
• Patient Weight: 2