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

Model Number	11590100
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Information (3190)
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 the iv tubing cracked.
Event or Problem Description
It was reported that the tubing cracked.
Additional Manufacturer Narrative
The customer¿s report that the tubing cracked was confirmed.During visual inspection clear liquid was observed inside model 11590100¿s tubing throughout the entire set.Functional testing was performed by filling a lab iv bag with blue dye water and spiking it to the set allowing fluid to flow via gravity.The set leaked from a small tear at the top of the silicone tubing segment below the upper fitment.Pressure testing confirmed the leak.The root cause of the tear could not be definitively determined.

• 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: 8908040
• Report Number: 9616066-2019-02289
• Device Sequence Number: 16778695
• Product Code: FPA
• UDI-Device Identifier: 10885403232411
• UDI-Public: 10885403232411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 07/24/2019

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: 11590100
• Device Catalogue Number: 11590100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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: NON-BD EXTENSION SET, TD UNK