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

Model Number	2420-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received, and patient demographic details were not provided.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that a check valve failure occurred on the primary set during a secondary infusion of piperacillin/tazobactam.No patient harm was reported.The event occurred on the surgical care unit.Received a copy of the customer's cmdsnet program report from health canada, which states, "clinical instructor was preparing a secondary iv medication (pip-tazo) with a student.After preparation the tubing was inserted into the alaris pump and the primary infusion was started.The secondary infusion was then programmed and the infusion start button was initiated.The secondary tubing clamp was opened and medication from the secondary bag began back-flushing into the normal saline bag that was being used for the primary infusion.Staff on the unit attempted to problem solve the issue but it appeared to be either pump or tubing related.".
Additional Manufacturer Narrative
(revised suspect set to 2420-0007) the customer¿s report of a back-check valve failure was not confirmed.No particulates were noted on the diaphragm membrane or solvent on the check valve component with no damages to the interior of the check valve or to the diaphragm.The primary set and secondary set were visually inspected for incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed.The check valve was also visually inspected under microscope.The check valve was noted to be assembled in the set correctly, and the silicone membrane was centered.Functional testing was performed resulting in no air bubbles or fluid observed going past the check valve or into the primary bag.The root cause of this failure was not identified.
Event or Problem Description
It was reported that a back-check valve failure occurred on the primary set during a secondary infusion of piperacillin/tazobactam.The event occurred on the surgical care unit.It was confirmed during follow-up that there was no patient harm as a result of this event.Received a copy of the customer's cmdsnet program report from health canada, which states, "clinical instructor was preparing a secondary iv medication (pip-tazo) with a student.After preparation the tubing was inserted into the alaris pump and the primary infusion was started.The secondary infusion was then programmed and the infusion start button was initiated.The secondary tubing clamp was opened and medication from the secondary bag began back-flushing into the normal saline bag that was being used for the primary infusion.Staff on the unit attempted to problem solve the issue but it appeared to be either pump or tubing related.".

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8773079
• Report Number: 9616066-2019-01879
• Device Sequence Number: 19249503
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• 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: foreign,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: 72213N; 8100,8015, UNK SECONDARY SET