MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MODULE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	30853
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
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.Patient age and dob requested but not provided, however, the customer stated that the patient was an adult male patient.
Event or Problem Description
It was reported that the pca tubing set was found to have small cracks which caused the medication to leak during use on a patient.The customer further stated that there were no adverse effects caused to the adult patient from the event.
Event or Problem Description
It was reported that the pca tubing set was found to have small cracks which caused the medication to leak during use on a patient.The customer further confirmed during follow up, that there were no adverse effects caused to the adult patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing cracked and leaked was confirmed based on visual inspection and functional testing.Inspection observed multiple cuts along the tubing.Leaks were observed from the damages during re-priming.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.It was observed there were multiple cuts along the tubing between the antisiphon valve and y-site components.No other obvious damages or issues were observed.The root cause of the damages was not identified.

• Brand Name: ALARIS PCA MODULE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9156106
• Report Number: 9616066-2019-02766
• Device Sequence Number: 2623093
• Product Code: FPA
• UDI-Device Identifier: 10885403273995
• UDI-Public: 10885403273995
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/09/2019

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 Model Number: 30853
• Device Catalogue Number: 30853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/16/2019
• 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: 8120,8015, THERAPY DATE 09/06/2019