MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N1191
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Alternate reporter phone number (cell): (b)(6).Device manufacturer address: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A pediatric patient experienced a blood loss during an overnight infusion of intralipids and total parenteral nutrition using a y-type catheter extension set.The caregiver reported the tubing was not cut or sliced, however, ¿appeared to have broken¿.The caregiver noted it was unknown how long the pump was not infusing as the event occurred overnight while the patient was sleeping.The amount of blood loss was unknown.The patient presented to the emergency room and required a blood transfusion.The patient was not hospitalized for the event.At the time of this report the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided photo was performed.The reported event was not observed as the provided picture was not clear and showed blood visible on the device.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: RADIATION STERILIZED EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10005757
• Report Number: 1416980-2020-02415
• Device Sequence Number: 741987
• Product Code: FPA
• UDI-Device Identifier: 00085412004532
• UDI-Public: (01)00085412004532
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• 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): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2024
• Device Catalogue Number: 2N1191
• Device Lot Number: R19I16055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR