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

Model Number	10013890
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
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 during an infusion the tubing appeared to have micro holes where the fluid appeared to seep from the tubing where the cartridge is inserted into the pump.It was reported no medical treatment was required as a result of the event.
Additional Manufacturer Narrative
The customer's report that during an infusion the tubing appeared to have micro holes where the fluid appeared to seep from the tubing where the cartridge is inserted into the pump was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A small hole was observed in the silicone tubing just below the upper fitment retainer ring.No gouge/crush marks were observed on the upper fitment.Clear liquid was observed in the set¿s drip chamber and entire length of tubing.No other abnormalities were observed with the set.Functional testing was performed.Blue-dyed water was observed to be dripping out of the location of the hole in the silicone segment tubing.The seeping of fluid was due to a hole in the silicone tubing just below the upper fitment retainer ring.The root cause of the hole could not be definitively determined.
Event or Problem Description
It was reported that during an infusion the tubing appeared to have micro holes where the fluid appeared to seep from the tubing where the cartridge is inserted into the pump.It was reported no medical treatment was required as a result of the event.

• 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: 10026616
• Report Number: 9616066-2020-01560
• Device Sequence Number: 11466459
• Product Code: FPA
• UDI-Device Identifier: 10885403232268
• UDI-Public: 10885403232268
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/20/2020

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 Model Number: 10013890
• Device Catalogue Number: 10013890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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,NON-BD LUER LOCK CONNECTOR,TD (B)(6) 2020; 8100,8015,NON-BD LUER LOCK CONNECTOR,TD (B)(6) 2020