MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRIM PLUMSET-SL PE-LINED; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1233912

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

A batch record review revealed no discrepancies that may have contributed to a complaint of this nature.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the final visual, physical evaluation results indicated that the product met specification requirements.

Event Description

The event occurred on an unknown date and involved a primary plumset, that during priming of total parenteral nutrition (tpn), an impurity was noted inside.The customer reported there were no obvious defects noted on the tubing set, including no holes, cuts, or tears.The tubing was replaced and therapy was started.There was no adverse event reported.Testing received one used 123390488 primary plumset orange pe lined light-resistant tubing, clave y-site, secure lock, 103 in, reported lot# 811435h was received for evaluation.Foreign material was observed inside the 69" tubing.The sample was not decontaminated due to investigation purposes.According to investigation findings, the manufacturing process was discarded and no probable cause was identified for the failure reported by the customer.

• Brand Name: LS PRIM PLUMSET-SL PE-LINED
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: emily arnould, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8669774
• MDR Text Key: 147068076
• Report Number: 9615050-2019-00179
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)200901(10)811435H
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 1233912
• Device Catalogue Number: 123390488
• Device Lot Number: 811435H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 05/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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