MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY MICRODRIP 150 ML BURETTE SET WITH FLOAT VALVE, PREPIERCED ADDITIVE PORT,; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 127280490

Device Problem Inaccurate Delivery (2339)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unknown date involving a primary microdrip 150 ml burette set with float valve, prepierced additive port, prepierced y-site, secure lock, 78 inch where it was reported that when testing burette on a couple of pumps with infusion pumps set up of 150ml to fill the patient, the pump said the total volume was infused but there¿s still 40ml left.They tested the burette again on a 2nd pump, it said the same thing, the total of volume was infused but there¿s still 32ml left on the bag.The customer believes that the problem came from the tubing since they have tested it in two pumps and got the same result.The event occurred during infusion, but she didn¿t have any information on what was infusing during the time of the event.Additionally, the customer stated that the ivf were started on (b)(6) 2023 at 4pm for the patient.Fluids stopped before discharge on (b)(6) 2023 at 10am.The issue was noticed when she took care of the patient for the first time on (b)(6) 2023 and marked the burette around 8am and told the ivf pump to deliver 150mls.The pump alarmed that the total volume was infused with 30 to 40mls still remaining, she is unsure what exact time that was but it's around 5pm or 6pm.The pump used was a heska vet/iv 2.2 infusion pump with serial number (sn) 72873 for the first patient.No tubing was replaced, suspected it was a fluke and to monitor.She came back to work next day and tested using a different pump and burette.She does not have the burette or the sn of that pump.The original error was found on 31-jul-00 and tested again 01-aug-00 and 02-aug-00 without patient attached.She is unsure if there was delay in therapy but there may have been detrimental if patient had a disease that needed more accurate fluids such as kidney disease or azotemia.This can also affect fluid additives.None were used for this patient.There was patient involvement but no harm.

Manufacturer Narrative

The device was received for evaluation.The investigation is still pending.

Manufacturer Narrative

Received one used 127280490 primary microdrip 150 ml burette set with float valve for inspection.No damages or anomalies noted.The set was primed per packaging directions then attached to a primed icu medical provided plum set and inserted into an icu medical provided plum a+ pump.A piggyback infusion was ran from the secondary port per product specifications for accuracy testing.The product met performance specifications.The reported complaint was unable to be replicated or confirmed.A device history report (dhr) could not be conducted because no lot number(s) was/were identified.

• Brand Name: PRIMARY MICRODRIP 150 ML BURETTE SET WITH FLOAT VALVE, PREPIERCED ADDITIVE PORT,
• 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: 17645184
• MDR Text Key: 322213407
• Report Number: 9615050-2023-00361
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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 Catalogue Number: 127280490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/19/2023
• 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
• Treatment: HESKA VET/IV 2.2 PUMP SERIAL (B)(6).; UNSPECIFIED IV FLUID, MFR UNK.