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

Model Number	2451-0007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that a mainline of lactated ringer was programmed at 20/hr.During an endoscopy procedure.The patient received iv sedation of midazolam and fentanyl and then was given a manual flush 10ml normal saline.Approximately 30 min later the user noticed set "blew apart¿ at an unspecified location.There was no report of patient harm.
Event or Problem Description
The customer reported that a mainline of lactated ringers was programmed at 20/hr (presumed to mean 20 ml/hr) during an endoscopy procedure.The patient received iv sedation of midazolam and fentanyl and then was given a manual flush of 10ml normal saline.Approximately 30 minutes later the user noticed that the set "blew apart¿ at an unspecified location.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that the set came apart was confirmed.Visual inspection showed a separation between the silicone pump segment tubing and the upper fitment.The ring retainer was not received with the set.A ring retainer indentation was observed around the end of the silicone pump tubing where the separation occurred.The silicone tubing was measured and found to be within specification.Functional testing could not be performed due to the separation.The root cause of the separation could not be determined.

• 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: 7910729
• Report Number: 9616066-2018-01750
• Device Sequence Number: 1449813
• Product Code: FPA
• UDI-Device Identifier: 10885403220432
• UDI-Public: 10885403220432
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 01/11/2021
• Device Model Number: 2451-0007
• Device Catalogue Number: 2451-0007
• Device Lot Number: 18015780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: 10ML SYRINGE, THERAPY DATE (B)(6) 2018