MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problems Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

The returned set was visually inspected and no anomalies were evident.The set was air pressure leak tested per product specifications and a leak was found at the outlet port, however, no tubing damage was found.The tubing od was measured and found to be within specification.The tubing was pulled from the socket, examined and evidence of incomplete solvent bond coverage was found.The complaint can be confirmed, the probable cause of the leak can be attributed to a bonding error.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

Event Description

It was reported that, on an unknown date, the nurse was having issues with the plumset involved in the event.The device is alleged to have a crack to the cassette at the insertion of the proximal tubing.The report states, the patient reported dripping from the pump during a milirone infusion and called the nurse into the room.There was a reported delay in treatment due to the need for a new bag of medication to be prepared and tubing replacement.There was no harm to the patient reported.

• Brand Name: NDEHP PLUMSET 2CLAVES-SL
• 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: 12139143
• MDR Text Key: 261241300
• Report Number: 9615050-2021-00092
• Device Sequence Number: 1
• Product Code: FPA
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• 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