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

Model Number	10014917
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	07/29/2018
Type of Reportable Event	Serious Injury
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
The customer reported that during an infusion of mso4 at 0.37ml/hr, the tubing leaked at the filter.The patient needed a prn dose of ativan as a result.No further issues were reported.
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked at the filter was confirmed.Visual inspection of the set showed no damage or anomalies.Functional testing confirmed leaking along the weld line of the pressure sensing disc between the disc body and the disc film membrane.The root cause of the leak was identified as an equipment failure causing a poor weld between the pressure sensing disc body and the film membrane.
Event or Problem Description
The customer reported that during an infusion of mso4 at 0.37ml/hr, the tubing leaked at the filter.The patient needed a prn dose of ativan as a result.No further issues were reported.

• 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: 7919802
• Report Number: 9616066-2018-01791
• Device Sequence Number: 1936776
• Product Code: FPA
• UDI-Device Identifier: 10885403233937
• UDI-Public: 10885403233937
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10014917
• Device Catalogue Number: 10014917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: 8110,8015,SYRINGE, THERAPY DATE (B)(6) 2018; 8110,8015,SYRINGE, THERAPY DATE (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Weight: 3