MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM BURETTE CLAVE SITES 114IN NDEHP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1427329

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a plum set that during infusion, when using the clave connector to deliver drug, there was blue suspended matter noted in the burette.The tubing was not replaced and the therapy was not resumed.It was reported that there were no obvious defects noted on the tubing set (cracks or breaks), no hole, cut, tears or any other defects noted.It was also reported that the set was stored in the storage place in the hospital and it was not exposed in extreme temperature condition.There was patient involvement and no patient harm.

Manufacturer Narrative

The complaint of a particulate inside the fluid path can be confirmed on the returned one used 142730490 plum burette set.As received there was a blue fiber particulate inside the large diaphragm of the plum cassette on the primary plum set burette cylinder.The particulate was submitted to a fourier-transform infrared spectroscopy (ftir) to determine the origin of the particulate.There were no significant correlation to any materials used during manufacturing.The origin and the probable cause of the particulate getting inside the fluid path is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg - january 4, 2021.

• Brand Name: PLUM BURETTE CLAVE SITES 114IN NDEHP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 11078270
• MDR Text Key: 224400268
• Report Number: 9615050-2020-00278
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)221201(10)4493029
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: 12/01/2022
• Device Model Number: 1427329
• Device Catalogue Number: 142730490
• Device Lot Number: 4493029
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1