MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LFS PPS15UMCV 1.2UMCVY SL264CM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140149290

Device Problem Particulates (1451)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It is yet to be received.

Event Description

The customer reported a primary plum set, 15 micron filter in sight chamber, clave secondary port, 0.2 micron filter, was in use for more than 3 hours for an infusion of paclitaxel, and when the nurse went to disconnect the administration set at the end of the infusion she noticed that the iv chamber had floating white particles, described as looking like lime scale in a kettle.It appeared that the small filter in the chamber began to disintegrate.The infusion was stopped and the device was removed from the patient.There was patient involvement and a report of unprotected chemo exposure, but no harm or delay in critical therapy were reported.

Manufacturer Narrative

One (1) used list# 140149290, ls, prim plum set, 15 micr flt sght chmb, clave scndry port, 0.2 micr flt, pe lined tbg, sl, 225 cm.Lot# unknown, one (1) used bag 100 ml, sodium choride 0.9% manufacturer baxter were received on august 20, 2019.The complaint of a particulate found within the fluid path on the returned primary plum set can be confirmed.As received, there were white particulates found inside the fluid path of the drip chamber.An ftir was done on the particulate found and no significant correlations were found.The probable cause and origin of the particulate is unknown.The device history review could not be reviewed due to the unknown lot number.

• Brand Name: LFS PPS15UMCV 1.2UMCVY SL264CM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8912164
• MDR Text Key: 155046582
• Report Number: 9615050-2019-00359
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 140149290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACLITAXEL, UNK MFR