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

Model Number	11607704
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Patient information was requested, but not provided.
Event or Problem Description
It was reported that the patient was hooked up to normal saline to another manufacture port.The tubing was broken at the y-site and the blood had started to flow out of the remaining tubing that was still attached to the patient.
Additional Manufacturer Narrative
Additional information added to: d10.Correction; h.6.(patient code).The customer¿s report that of the tubing was broken at the y-site was confirmed.It was determined to be tubing separation from the inlet port of the distal smartsite.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.The primary set¿s tubing was separated from the inlet port of the distal smartsite.Clear liquid was observed in both set¿s drip chambers and entire length of tubing.No other abnormalities were observed on the sets during visual inspection.Further visual inspection of the set¿s separated tubing using a microscope observed insufficient solvent on the tubing.Functional testing was not performed due to the separated tubing and the leaking that would occur.The root cause of the separation was identified as a manufacturing issue for insufficient solvent being applied at the engagement of the tubing to the smart-site inlet due to equipment and/or operator error.
Event or Problem Description
It was reported that the patient was hooked up to normal saline (ns) to another manufacture port.The tubing was broken at the y-site and the blood had started to flow out of the remaining tubing that was still attached to the patient.The patient was attached to one used 100ml baxter galaxy single dose container, and cefepime injection 2g.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9410031
• Report Number: 9616066-2019-03533
• Device Sequence Number: 19884207
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/15/2019

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 Expiration Date: 08/19/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19087383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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: THERAPY DATE: UNKNOWN.