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
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.Patient is caucasian.
Event or Problem Description
It was reported that during a child¿s infusion with two medications and two pump modules, the sodium chloride set disconnected at the luer connection to the milrinone set.The event set was connected to the milrinone set luer closest to the patient's iv catheter.The event set infused maintenance fluid (500 ml bag of 0.45% sodium chloride) at an unknown rate.The set attached to the iv catheter contained milrinone (100 ml bag infusing at 1.82 ml/hr).The clinician stated that no infection or patient harm occurred as a result of the disconnection, and the sets were sequestered for investigation.Although requested, no other event or patient details were provided.
Additional Manufacturer Narrative
Additional information provided: d.10 the customer¿s report of an unintended disconnection at the distal smartsite 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 root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that during a child¿s infusion with two medications and two pump modules, the sodium chloride set disconnected at the luer connection to the milrinone set.The event set was connected to the milrinone set luer closest to the patient's iv catheter.The event set infused maintenance fluid (500 ml bag of 0.45% sodium chloride) at an unknown rate.The set attached to the iv catheter contained milrinone (100 ml bag infusing at 1.82 ml/hr).The clinician stated that no infection or patient harm occurred as a result of the disconnection, and the sets were sequestered for investigation.Although requested, no other event or patient details were provided.

• 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: 8483381
• Report Number: 9616066-2019-00887
• Device Sequence Number: 13846934
• 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