MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	30893-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, no additional information provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the tubing leaks from the distal end where the port is connected.This is a recurring problem across multiple lots.The problem cannot be detected until the line is in the patient and in use.Discussed with staff in central distribution for this facility system.They are seeing this problem at multiple facilities and in multiple lots.The manufacturer has been notified and product has been returned.Multiple reports are being sent to the manufacturer about this problem." an incomplete date of event of (b)(6) 2020 was provided.It was reported that the medication infusing at the time was "epidural medications." there was no patient or clinician harm as a result of the event.The event did not cause a delay that significantly impacted patient outcomes.Although requested, no patient details provided.
Additional Manufacturer Narrative
Additional information: d.4.Correction; g.3, e.2, and e.3.No product will be returned per customer.No investigation was performed.The root cause of the customer's report could not be determined.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the tubing leaks from the distal end where the port is connected.This is a recurring problem across multiple lots.The problem cannot be detected until the line is in the patient and in use.Discussed with staff in central distribution for this facility system.They are seeing this problem at multiple facilities and in multiple lots.The manufacturer has been notified and product has been returned.Multiple reports are being sent to the manufacturer about this problem." an incomplete date of event of (b)(6) 2020 was provided.It was reported that the medication infusing at the time was "epidural medications." there was no patient or clinician harm as a result of the event.The event did not cause a delay that significantly impacted patient outcomes.Although requested, no patient details provided.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9809194
• Report Number: 9616066-2020-00800
• Device Sequence Number: 11485536
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 04/24/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19046125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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: 8015,8120, PRI TUBING, TD UNK.
• Patient Age: 21 YR