MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRIM PLUMSET-SL PE-LINED; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1233912

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The event involved a plum set in which the reporter stated ¿after giving a chemotherapy drug drip in bed and replacing it with a normal saline solution bag to wash out the chemotherapy drug, the chemotherapy drug was found to be leaking where the administration adapter connects to the light-resistant set, and the chemotherapy drug had leaked onto the floor, patient's bed rail, and sheet.As soon as the chemotherapy drug splashed, the contaminated area was cleaned and the cleaning attendant was told to increase sterilization.¿ there was patient involvement; no harm was reported as a consequence of this event.

• Brand Name: LS PRIM PLUMSET-SL PE-LINED
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 12414465
• MDR Text Key: 269556166
• Report Number: 9615050-2021-00131
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)221201(10)4411936
• 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
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 1233912
• Device Catalogue Number: 123390488
• Device Lot Number: 4411936
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• 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: NORMAL SALINE, MFR UNK; UNSPECIFIED CHEMOTHERAPY, MFR UNK