MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142730490

Device Problems False Alarm (1013); No Flow (2991)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation, however, investigation is not yet complete.E1 - additional contact information (b)(6).(b)(6).Product manager (b)(6).

Event Description

The event involved an plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in where the customer reported that the device gave n185 alarm code during patient infusion.The customer stated that they tried 2 different plum a+ pumps and they were having same issue.The customer stated that there were no issues with the pumps as they worked fine with other sets.The solution being infused was normal saline.There were no obvious defects such as crack/break/cut/hole/tear noted on the tubing set.The tubing set was replaced and therapy resumed.The product was stored in the air-conditioned room in the hospital and was not exposed to extreme temperature.There was patient involvement but no patient harm.This is report six of six.

Manufacturer Narrative

The used 140073190 plum burette set was received for inspection.No visual damages or anomalies noted.The set was attached to an icu medical provided iv bag, primed per packaging directions and a flow test was performed using an icu plum pump.There were no difficulties in priming, no cassette errors, no occlusion alarms or air in line alarms were generated and no restrictions in flow were observed.The reported complaint of a proximal occlusion alarm was unable to be replicated on the received sample.The complaint of n185 alarm can be confirmed based on lot history.The probable cause of the occlusion alarm is related to material variability in cassette diaphragm stiffness which could cause an increase in the frequency of proximal occlusion alarms, corrective actions are in process.

• Brand Name: PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18356948
• MDR Text Key: 330893281
• Report Number: 9615050-2023-00799
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)260401(10)13547923
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142730490
• Device Lot Number: 13547923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE, MFR UNK; PLUM A+ INFUSION PUMP, ICU MEDICAL