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 Problem Fracture (1260)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved an unspecified pe tubing set with an alleged broken back prime clave.There was no report of human harm.

Manufacturer Narrative

The device is available for evaluation, however, has not been received yet.Ei initial reported full phone number: (b)(6).

Manufacturer Narrative

Received one used 146870489 primary plum set and one used list #unknown primary plum set for inspection.Sample 1 was tested per product specifications.There was no leakage and a flow test was performed using an icu plum pump.There were no difficulties in priming, no cassette errors, no occlusion alarms were generated, no air in line alarms were generated and no restrictions in flow were observed.Fluid was infused through the secondary port with no restrictions in flow.It is unknown if the sample 2 assembly includes a high pressure clave on the secondary port.The set was tested per product specifications.There was no leakage and a flow test was performed using an icu plum pump.There were no difficulties in priming, no cassette errors, no occlusion alarms were generated, no air in line alarms were generated and no restrictions in flow were observed.The reported complaint was unable to be replicated or confirmed.A device history record review could not be conducted because no lot number was identified.D9 - date returned to mfg: (b)(6) 2023.

Event Description

Additional information from the customer was received indicating that the issue was identified and occurred during infusion.

• 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 NONE ; CS NONE
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18422130
• MDR Text Key: 331674418
• Report Number: 9617594-2023-01210
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• 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: 01/26/2024

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 Catalogue Number: 146870489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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