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

Model Number	10798696
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
Received a copy of the customer's sus voluntary event report from fda which states, ¿iv tubing leaking at filter site, no harm to pt." the customer later reported that when the nurses attempted to prime the tubing sets, it was found that they leaked around the filter and would not prime.This happened two separate times, one on (b)(6) 2019 and the other set on (b)(6) 2019, as well as, there has been several reported events over the past two or three months.There was no patient involvement as the event occurred prior to patient use.
Event or Problem Description
Received a copy of the customer's sus voluntary event report from fda which states, ¿iv tubing leaking at filter site, no harm to pt." the customer later reported that when the nurses attempted to prime the tubing sets, it was found that they leaked around the filter and would not prime.This happened two separate times, one on (b)(6) 2019 and the other set on (b)(6) 2019, as well as, there have been several reported events over the past two or three months.Upon receipt of the returned products, it was found that it was stated on a hand-written note that one of the reported tubing sets filter leaked after being in use for 2 hours.The customer further stated that there were no adverse effects caused to patients from the events.
Additional Manufacturer Narrative
Correction to follow up 1.
Event or Problem Description
The customer later reported that when the nurses attempted to prime the tubing sets, it was found that they leaked around the filter and would not prime.This happened two separate times, one on (b)(6) 2019 and the other set on (b)(6) 2019 as well as, there have been several reported events over the past two or three months.Upon receipt of the returned products, it was found that it was stated on a hand-written note that one of the reported tubing sets filter leaked after being in use for 2 hours.The customer further stated that there were no adverse effects caused to patients from the events.
Additional Manufacturer Narrative
Additional information provided:description of event or problem & concomitant medical products.The customer report of leaking tubing was confirmed based on functional testing performed on the two as-received set samples.Set 1 was visually inspected for kinks, holes/tears in the tubing or damages to the components.No obvious damages or any issues were observed.Set 2 was visually inspected for kinks, holes/tears in the tubing or damages to the components.No obvious damages or any issues were observed leaks were observed on each set- on set 1, at the engagement of the tubing to filter inlet port; and on set 2, at the engagement of the filter outlet port to tubing.Inspection of the leaking engagements each observed a gap within indicating that the expected tubing was not fully inserted.Dimensional analysis of the tubing outer diameter was measured and was within specification.The identified root cause is a gap (tubing not fully inserted into filter component) due to operator error during set assembly.

• Brand Name: ALARIS SYRINGE MODULE SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9107685
• Report Number: 9616066-2019-02723
• Device Sequence Number: 2430621
• Product Code: FPA
• UDI-Device Identifier: 10885403234354
• UDI-Public: 10885403234354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2019

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: 04/03/2022
• Device Model Number: 10798696
• Device Catalogue Number: 10798696
• Device Lot Number: 19045397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 12/16/2019; 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1