MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142560488

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

The event involved a primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch where a chemo, paraplatin (150 mg/15 ml /vial) drug leak during infusion was reported.Drug preparation: 500mg (3.33 vial) if once in d5w 500ml.A patient¿s port-a-cath was connected to paraplatin.The infusion flow rate was set to 183ml/ hr.During infusion, the bed sheets were found wet.The healthcare provider checked the infusion set and confirmed the leakage on micron filter.The patient's right hand had in contact with the chemo drug.The contact position was immediately flushed with water for 15 minutes.No redness, swelling or injury was detected on the hand.The spill volume was unknown, but very little.The set was replaced, and therapy resumed.There was patient involvement but no patient harm.This is the first of two events.

Manufacturer Narrative

E1 - initial reporter phone has an extension number of (b)(6).The device was received for evaluation.The investigation is pending.

Manufacturer Narrative

Received two used list #142560488 primary plum sets.Sample #1 was attached to a bag spike adaptor, a bag spike w/ clave and a 0.9% sodium chloride bag.No other damage or anomalies noted.The returned samples were leak tested per product specification.No leakage was observed on sample 1.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18908739
• MDR Text Key: 337758310
• Report Number: 9615050-2024-00233
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005230
• UDI-Public: (01)10887787005230(17)260701(10)13670702
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142560488
• Device Lot Number: 13670702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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: PARAPLATIN (150 MG/15 ML /VIAL), MFR UNK; PORT-A-CATH, MFR UNK