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

Model Number	10015862
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
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 tubing set separated at the drip chamber and leaked while priming with magnesium sulfate 6 g (10g/20ml)/150 ml to infuse at a rate of 2 g/hr for a duration of 3 hours.There was no patient involvement since the set did not make it to the bedside.
Event or Problem Description
It was reported that tubing set separated at the drip chamber and leaked while priming with magnesium sulfate 6 g (10g/20ml)/150 ml to infuse at a rate of 2 g/hr for a duration of 3 hours.There was no patient involvement since the set did not make it to the bedside.
Additional Manufacturer Narrative
The customer¿s complaint of tubing set separated and leaked was confirmed.The separation was observed at the engagement between the outlet spigot of the drip chamber and tubing on set received.Functional testing was not performed as the customer's report was confirmed upon visual inspection.Dimensional testing measured the tubing to be within specification.Device history record for model 10015862 lot 20035131 shows that the set was manufactured on 3 march 2020 with a total of 11,523 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The root cause of the tubing separation was a manufacturing issue for insufficient solvent being applied at the affected engagement due to equipment and/ or operator error.

• 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: 10083636
• Report Number: 9616066-2020-01720
• Device Sequence Number: 2861712
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: 10885403221866
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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 Expiration Date: 03/03/2023
• Device Model Number: 10015862
• Device Catalogue Number: 10015862
• Device Lot Number: 20035131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1