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)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 500 ml bag of 0.45% sodium chloride, therapy date (b)(6) 2019.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Child is caucasian.
Event or Problem Description
It was reported that during a milrinone infusion (100 ml bag infusing at 1.82 ml/hr), an unintended disconnection of the pump tubing to the child's iv access device occurred despite thoroughly tightening the tubing prior to the start of the infusion.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.Also connected to the patient at the distal y-site closest to the patient's catheter was an additional primary administration set infusing a 500 ml bag of 0.45% sodium chloride.
Event or Problem Description
It was reported that during a milrinone infusion (100 ml bag infusing at 1.82 ml/hr), an unintended disconnection of the pump tubing to the child's iv access device occurred despite thoroughly tightening the tubing prior to the start of the infusion.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.Also connected to the patient at the distal y-site closest to the patient's catheter was an additional primary administration set infusing a 500 ml bag of 0.45% sodium chloride.
Additional Manufacturer Narrative
Additional information provided: the customer¿s report of an unintended disconnection was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in the set flowing freely and showed no signs of disconnecting anywhere throughout the sets.The male luer ports or both sets were measured and found to be within iso standards with the female go/nogo gauges.The customer did not send in the catheter that was reportedly disconnecting from the set.The root cause of the customer¿s report was not identified.

• 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: 8483066
• Report Number: 9616066-2019-00889
• Device Sequence Number: 1955509
• 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: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 04/04/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: C24103E,PERIPHERAL CATHETER, THERAPY DATE (B)(6) 2019; C24103E,PERIPHERAL CATHETER, THERAPY DATE (B)(6) 2019
• Patient Age: 18 MO
• Patient Weight: 8