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

Model Number	11607704
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: ias information & analytics services.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Concomitant medical products: curos cap/central line.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿iv fluids dripping out of y site port.Unknown if the patient was receiving fluid.Iv tubing lot # 19055609." it was reported that dextrose d50 was programmed at a rate 50ml/hr.Via central line, the user stated that the tubing was correctly inserted into the device however when the nurse removed the curos cap a leak was noted at the smartsite valve proximal to the drip chamber.It was later reported that nursing practice was to place curos caps on all smartsite valves if connected to a central line.There was no report from the customer of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak at the smartsite valve proximal to the drip chamber was not confirmed.Functional testing of priming, infusion, and pressure testing did not replicate any instances of leaking at the proximal smartsite port or anywhere else with the received sets.Received 32 new unopened primary sets.The customer did not send in the suspect set this event took place on.The sets were loaded into a lab pump module for an infusion test.The primary infusion was programmed at a rate of 50ml/h and 50 ml vtbi.The infusions completed with no alarms and no signs of leaking at the proximal smartsite port or anywhere else throughout the sets.Sets were then pressure tested while submerged underwater.Air pressure was incrementally increased from 5 psi to 30 psi.There were no signs of leaking anywhere on the returned sets while the tubing was manipulated at each engagement.The root cause could not be identified.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿iv fluids dripping out of y site port.Unknown if the patient was receiving fluid.Iv tubing lot # 19055609." it was reported that dextrose d50 was programmed at a rate 50ml/hr.Via central line, the user stated that the tubing was correctly inserted into the device however when the nurse removed the curos cap a leak was noted at the smartsite valve proximal to the drip chamber.It was later reported that nursing practice was to place curos caps on all smartsite valves if connected to a central line.There was no report from the customer of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak at the smartsite valve proximal to the drip chamber was confirmed via the video evidence the customer sent in.The video evidence was reviewed and confirmed that a leak occurred at the distal smartsite port.The root cause of the customer¿s report could not be identified because the suspect set was not sent in for investigation and no leaks were observed or replicated at the proximal smartsite port or anywhere else on the received associate sets during internal lab testing.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿iv fluids dripping out of y site port.Unknown if the patient was receiving fluid.Iv tubing lot # 19055609." it was reported that dextrose d50 was programmed at a rate 50ml/hr.Via central line, the user stated that the tubing was correctly inserted into the device however when the nurse removed the curos cap a leak was noted at the smartsite valve proximal to the drip chamber.It was later reported that nursing practice was to place curos caps on all smartsite valves if connected to a central line.There was no report from the customer of patient harm.

• 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: 8859856
• Report Number: 9616066-2019-02152
• Device Sequence Number: 11219684
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 07/10/2019

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 Expiration Date: 05/08/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19055609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/08/2019; 08/27/2019
• 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: 8100,8015, THERAPY DATE (B)(6) 2019; CUROS CAP/CENTRAL LINE
• Patient Age: 72 YR
• Patient Weight: 72