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

Model Number 1468728

Device Problem Backflow (1064)

Patient Problem No Code Available (3191)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received on december 21, 2018.Testing and investigation is in progress.

Event Description

This is report 2 of 2 capturing the primary plumset for this one event that occurred in room 12 on (b)(6) 2018.The event involved a primary plumset that the customer reported blood was backing up in the line and the tubing was flattened down.It was reported that unspecified total parenteral nutrition (tpn) was being delivered via a peripherally inserted central catheter (picc) line at 4.32ml/hr via a plum 360 pump.Eight hours into the infusion, it was noted that there was a ¿large amount of air and the tubing collapsed above the cassette.¿ it was reported that actions taken were that they ¿had to remove picc and new picc had to be placed.¿ the patient was in room 12 of the neonatal intensive care unit (nicu), was 30.6 weeks gestation and weighed 1850 grams.

Manufacturer Narrative

Received three (3) open, used list number 14687 plumsets for evaluation.The reported kinked tubing was confirmed by investigation in all of the returned sets.As received, multiple kinks were observed in the tubing.However, because all of the returned sets were received open, out of package, and used it is possible that the observed kinks were exacerbated during shipping to icu medical for investigative purposes or additional kinks were induced.Potential causes of the observed kinking is twisting of the tubing during coiling, the configuration of the set in the product package or the shipping container, or a combination thereof.All sets passed all functional tests per the product specifications and the observed kinked tubing did not affect product performance during investigative testing.The reported backflow was not confirmed by investigation.Backflow was not observed under conditions representative of correct use even when back pressure.Arterial pressure was applied to the plumset.Backflow was only replicated when an open line external to the plumset was present or the plum cassette was not inserted into the plum pump, the flow regulator was open, and an appropriate pressure differential existed.As no lot number was identified, a manufacturing batch record review, maintenance routines and maintenance work orders (wo) to this nature could not be performed.

• 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
• MDR Report Key: 8261012
• MDR Text Key: 133542947
• Report Number: 9615050-2019-00006
• Device Sequence Number: 1
• Product Code: FPA
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PLUM 360 PUMP, #300100409; UNSP TPN; PLUM 360 PUMP, #300100409; UNSP TPN
• Patient Outcome(s): Required Intervention
• Patient Weight: 1