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

Model Number	30916-07
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿insulin hooked up to pressure sensitive disc tubing.All insulin ended up on floor because pressure disc on tubing had crack/cut on disc and fluid leaked out when priming the line.No harm to patient other than delay of treatment." an incomplete date of event of (b)(6) 2020 was provided.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿insulin hooked up to pressure sensitive disc tubing.All insulin ended up on floor because pressure disc on tubing had crack/cut on disc and fluid leaked out when priming the line.No harm to patient other than delay of treatment.".
Additional Manufacturer Narrative
The customer¿s report that the pressure disc on the tubing had a crack/cut (slice) and fluid leaked was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a slice damage on the pressure sensing disc film¿s membrane.No damages were observed on the product packaging pouch and no other anomalies were observed.Functional testing confirmed small droplets leaking from the damage of the pressure disc¿s film membrane.The root cause of the slice damage could not be determined.A device history record for model 30916-07 with lot number 19115555 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 06nov2019.The search showed that there were no quality notifications for the failure mode reported by the customer.

• Brand Name: ALARIS SYRINGE MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9917138
• Report Number: 9616066-2020-01236
• Device Sequence Number: 14150444
• Product Code: FPA
• UDI-Device Identifier: 10885403235238
• UDI-Public: 10885403235238
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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 Expiration Date: 11/06/2022
• Device Model Number: 30916-07
• Device Catalogue Number: 30916-07
• Device Lot Number: 19115555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: BD 10ML SYRINGE, THERAPY DATE UNK; THERAPY DATE 02/01/2020
• Patient Age: 2 DA