MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LFS PPS PPY PENOLITEDSTMICRSL104IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1425628

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however it has not been received.

Event Description

The event involved a plum set, where it was reported there were dirty marks on the sight chamber.It was reported that the event occurred during priming of normal saline.There was no obvious defects noted on the tubing set, and no holes, cuts, tears or any other defects noted.The tubing was replaced and therapy resumed.No leaks or damage were noted such as occlusions, kinks, bends, and no cassette test failure noted.There was no patient involvement and no patient harm reported.

Manufacturer Narrative

One used list #142560488, primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch; lot #5787358, one used list #unknown, bag spike adaptor w/ spiros lot #unknown.One used list #unknown, bag spike w/ clave lot #unknown was received for evaluation on (b)(6) 2022.A photo was returned by the customer showing what appeared to be burnt embedded material on the drip chamber.As received, multiple black spots were confirmed visible in the drip chamber.The drip chamber was cut open and the particles were confirmed to be embedded in the drip chamber wall, not in the fluid path.The combined area of these particles exceeds the allowable surface area of embedded or attached foreign material per product specifications.The most probable cause is burnt material embedded in the wall of the drip chamber during the molding process.While the device fails visual inspection, the embedded material is not in the fluid path, and does not affect the functionality of the device.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: LFS PPS PPY PENOLITEDSTMICRSL104IN
• 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: 15503099
• MDR Text Key: 302269556
• Report Number: 9615050-2022-00216
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005230
• UDI-Public: (01)10887787005230(17)250301(10)5787358
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1425628
• Device Catalogue Number: 142560488
• Device Lot Number: 5787358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: NORMAL SALINE, UNK MFR.