MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECNDRY SET 34IN NDEHP W/EXT HOOK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1423028

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.The lot number of the device that was in use is unknown.The customer identified two possible lot numbers: 5419064 (expiry date 06/01/2024, mfr date 06/01/2021) and 5283268 (expiry date 05/01/2024, mfr date 05/01/2021).Uf/importer report#: (b)(4).

Event Description

The event occurred on an unspecified date and involved a secondary set 34in ndehp w/ext hook.The customer reported that they filed a medsun mandatory medwatch report and provided reference (b)(4).The medsun report stated the following information: "i was hanging calcium chloride as a secondary medication.I programmed the pump to infuse over the standard 1 hour.I then started to do other task in my patient's room.I then took a glance at the iv pump and noticed that my calcium chloride had finished being infused but it had only been a few minutes since i had hung the infusion.I told my charge nurse and we agreed i needed to change out the iv pump channel and brain.I then proceed to hang magnesium sulfate as another secondary medication.I programmed the pump to infuse over the standard 1 hour.I watched the infusion start and noticed that it was dripping in faster than normal.I also noticed that even when the medication was paused, the secondary medication (magnesium sulfate) was still continuing to drip in.At this time i clamped the secondary tubing.I then changed out the tubing and secondary tubing and restarted the medications.The medication started to infuse correctly." upon further follow-up with the customer, it was reported that the pump in use at the time of the event was determined to be unrelated to the over-delivery as the issue occurred for a second time when they changed out the pump.It was also reported that the when the primary infusion was paused on the pump, the medication continued to drip in the drip chamber.When asked whether there were any issues with the secondary set, the customer stated that they could not definitively answer but that the secondary set did cease infusion when it was clamped and the primary set continued to infuse at the incorrect rate.The customer reiterated that they were unable to make any determination as to whether or not the secondary set did or did not fail.There was no report of harm or adverse event and the patient's condition was reported as "fine".

Manufacturer Narrative

The customer's complaint of over delivery could not be confirmed by investigation.No product samples or videos were received for investigation.Multiple photos were provided showing the set and the packaging.No damages or anomalies can be observed on the photos provided.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.

• Brand Name: SECNDRY SET 34IN NDEHP W/EXT HOOK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 12748597
• MDR Text Key: 280098531
• Report Number: 9615050-2021-00155
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1423028
• Device Catalogue Number: 142300428
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ALARIS INFUSION PUMP, MFR BD; CALCIUM CHLORIDE, MFR UNK; MAGNESIUM SULFATE, MFR UNK; UNSPECIFIED PRIMARY INFUSION SET, MFR BD