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

Model Number	C24103E
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, were not provided.Patient is caucasian.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that an unintended disconnection of the pump tubing to the child's iv access device occurred despite thoroughly tightening the tubing.The nurse stated that the peripheral catheters are often placed in the crease of the leg where the upper leg meets the groin/upper abdomen.No patient harm was reported.
Additional Manufacturer Narrative
The customer¿s report of an unintended disconnection was not confirmed.The tubing set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the received set.Functional testing was performed by filling the lab iv bag with blue dye water and attaching it to the set allowing fluid to flow through the whole set via gravity.The set flowed freely and showed no signs of disconnecting anywhere throughout the set.The set was then pressure tested while submerged underwater.Air pressure was incrementally increased from 5 psi to 30 psi.There were no signs of disconnecting anywhere on the returned set while the tubing was manipulated at each engagement.The root cause of the customer's report could not be determined.
Event or Problem Description
It was reported that an unintended disconnection of the pump tubing to the child's iv access device occurred despite thoroughly tightening the tubing.The nurse stated that the peripheral catheters are often placed in the crease of the leg where the upper leg meets the groin/upper abdomen.No patient harm was reported.

• 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: 8481052
• Report Number: 9616066-2019-00863
• Device Sequence Number: 13861579
• Product Code: FPA
• UDI-Device Identifier: 07613203021371
• UDI-Public: 7613203021371
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/08/2019

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: C24103E
• Device Catalogue Number: C24103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/13/2019
• 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, TD UNK