MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140159291

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

The event involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, 0.2 micron filter, clave y-site, polyethylene lined tubing, secure lock, 272 cm.It was reported that the plum 360 cassette that had fallen apart and fractured upon removal from pump at the completion of a chemotherapy infusion.The line snapped as the nurse was removing (de-lining) it from the pump, exposing him or her to cytotoxic chemotherapy.The saline flush was completed when the reported event occurred.There was no patient involvement, no delay in therapy and no specific human harm reported.

Manufacturer Narrative

The device is not available for investigation.The customer provided a photograph that is pending review.A supplemental emdr will be sent once the photo is evaluated.

Manufacturer Narrative

Several photographs were provided by the customer showing the cassette of the 140159291 primary plum set.The clave at the secondary port was observed to be broken.The shape of the deformation was angled where one side is higher than the other, typical of a bend break.The reported complaint of a broken secondary port can be confirmed.The probable cause is due to an unintentional bending force during use.Corrected information can be found in b3 - date of event.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16280266
• MDR Text Key: 308856520
• Report Number: 9615050-2023-00023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100197
• UDI-Public: (01)10887709100197(17)250401(10)5935440
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 140159291
• Device Lot Number: 5935440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CHEMOTHERAPY, MFR UNK.