MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SEC. PORT, CLAVE Y-SI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140073190

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

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event has not been received for investigation by the manufacturer.As additional information becomes available; a supplemental report will be submitted.

Event Description

It was reported that the plum set has an internal stain on the cassette, inside the fluid path, that could contaminate the total parenteral nutrition (tpn) infusate.The event was noticed during removal from packaging.There was no patient involvement reported.No additional information is available at this time.

Manufacturer Narrative

The set was visually inspected and a particle was found inside of the cassette.No other stains or particles were found anywhere else along the set.The particle was found to be roughly equal to 1.00mm^2.Close examination under the microscope found that the particle was embedded in the material and not in the fluid path.The reported complaint can be confirmed.The most probable cause is burnt material embedded in the wall of the cassette 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.Additional information in d9 (date returned to mfg) ¿ 8/27/2021.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SEC. PORT, CLAVE Y-SI
• 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: 12288386
• MDR Text Key: 265406540
• Report Number: 9615050-2021-00109
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709101514
• UDI-Public: (01)10887709101514(17)240101(10)5105254
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 140073190
• Device Lot Number: 5105254
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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