MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 146870489

Device Problems Fluid/Blood Leak (1250); No Flow (2991)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

The actual sample was discarded, however, photo sample is reported to be available, however, investigation is not yet complete.

Event Description

The event occurred on an unspecified date and involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.The reported stated that the pump does not allow back priming to b line as pump is detecting an occlusion.The a line could not be flushed either due to the occlusion message.The reporter stated that the event occurred while there was still medication distally from the pump.Fluid started leaking out from b line clave cap when nurse removed primary set from the pump to replace with another primary set.The issue was reported to have resulted in exposure of medication to nurse and high risk for exposure for the team.There was a delay in therapy as the treatment was delayed until situation was investigated and primary tubing changed.The primary tubing was replaced and there were able to resume the infusion.The issue was resolved by replacing the primary tubing.The reported added that should any future incident occurred , they will turn the pump off or resetting administration settings in attempt to overpass the occlusion message and attempt to flush primary line.The incident occurred during patient use but no patient harm was reported as a consequence of this event.

Manufacturer Narrative

Two photos were provided by the customer for evaluation.A stick down was observed at the clave at the secondary port.A proximal occlusion alarm for line b was observed on the plum pump.No samples were returned for investigation.The reported complaint of no flow and leakage can be confirmed from the photos provided due to the stick down at the secondary port of the clave.The cause of the stick down is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• 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: 18034860
• MDR Text Key: 327166733
• Report Number: 9615050-2023-00584
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260601(10)13605453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 146870489
• Device Lot Number: 13605453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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: UNSPECIFIED INFUSION PUMP, MFR UNK.; UNSPECIFIED MEDICATION, MFR UNK.