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

Model Number	2443-0600
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cont'd medical devices: d5w/0.9% nacl/ kcl and tpn bag.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 device alarmed for neoi (near end of infusion), and the tpn burette was empty with the clamp closed.The user opened the clamp and slightly pressed the burette to fill it; however, the burette cracked with a loud popping sound.The user immediately clamped and stopped the infusion, and removed the tubing.A change in solution of d5w/0.9% nacl with kcl was ordered and hung, and pharmacy was notified for a new tpn replacement bag.A separate infusion of lipids at an unspecified rate remained infusing.It was reported the last tubing change was (b)(6) and it was due to be changed on (b)(6).There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s complaint of a cracked burette was confirmed from a photo received from the customer.Evaluation of the photo showed a vertical crack along the front of the cylinder.The root cause of the crack was not identified.
Event or Problem Description
The customer reported that the device alarmed for neoi (near end of infusion), and the tpn burette was empty with the clamp closed.The user opened the clamp and slightly pressed the burette to fill it; however, the burette cracked with a loud popping sound.The user immediately clamped and stopped the infusion, and removed the tubing.A change in solution of d5w/0.9% nacl with kcl was ordered and hung, and pharmacy was notified for a new tpn replacement bag.A separate infusion of lipids at an unspecified rate remained infusing.It was reported the last tubing change was september 8 and it was due to be changed on september 12.There was no report of patient 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: 7882125
• Report Number: 9616066-2018-01710
• Device Sequence Number: 1908314
• Product Code: FPA
• UDI-Device Identifier: 10885403235061
• UDI-Public: 10885403235061
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2443-0600
• Device Catalogue Number: 2443-0600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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: (2)8100, 8015, PRI TUBING, TD (B)(6) 2018; (2)8100, 8015, PRI TUBING, TD (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention