MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO INTERLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C7557
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a vented paclitaxel set leaked.During patient infusion with docetaxel (rate of 262ml over one hour), a leak was observed ¿around the filter at the end of the filter¿.The event occurred approximately 40 minutes into the infusion via an unspecified pump.The drug leaked onto the floor under the bag.A chemo spill kit was used for cleanup.There was no unintended drug exposure to the patient or clinician.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a companion sample was received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.Visual inspection was performed with the naked eye and no defect was observed that could cause a leak.All components are correctly placed and according to the specifications.Pressure testing and clear passage under water testing (under water at eight (8) pounds per square inch) were performed with no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 7432878
• Report Number: 1416980-2018-02170
• Device Sequence Number: 16573153
• Product Code: FPA
• UDI-Device Identifier: 00085412036373
• UDI-Public: (01)00085412036373
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 08/23/2021
• Device Catalogue Number: 2C7557
• Device Lot Number: R16H23098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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: DOCETAXEL; UNSPECIFIED PUMP
• Patient Age: 64 YR