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

Model Number	10015294
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that tubing cracked and leaked.While gathering tubing to prime, the nurse punctured a 250ml bag of vancomycin and had contents of the bag leak on the floor.The issue appears to be the blue hub that is placed in pump had a crack and that is the site that the solution leaked from.There was no patient involvement.
Event or Problem Description
It was reported that tubing cracked and leaked in the dsu.While gathering tubing to prime, the nurse punctured a 250ml bag of vancomycin and had contents of the bag leak on the floor.The issue appears to be the blue hub that is placed in pump had a crack and that is the site that the solution leaked from.There was no patient involvement.
Additional Manufacturer Narrative
The customer¿s report of a leak at the engagement between the tubing and lower fitment was confirmed by functional testing.Visual inspection under microscope of the leaking engagement found that the tubing was not fully inserted into the lower fitment.No other anomalies were observed.The root cause of the leak is due to the tubing not being fully inserted into the lower fitment.Device history record for model 10015294 could not be performed due to no lot number being provided by customer.

• 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: 9913447
• Report Number: 9616066-2020-01130
• Device Sequence Number: 16926901
• Product Code: FPA
• UDI-Device Identifier: 10885403227981
• UDI-Public: 10885403227981
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 03/04/2020

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: 10015294
• Device Catalogue Number: 10015294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1