MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 09/28/2022

Event Type  Death  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Should additional information or sample be received, a supplemental report will be submitted.

Event Description

The event occurred on an unknown date and involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.It was reported that a patient died of an air emboli while attached to the plum set tubing that was infusing via gravity with an inflated pressure bag attached.This happened on the night shift of the go live day.A ct scan confirmed the presence of the reported air.The hospital risk manager was notified after the patient had already been transported to the morgue.The emergency department physician was adamant that the device¿s packaging contraindicated high pressure.Conversely, it was reported that hospital staff was informed that a pressure bag was acceptable for use.The manufacturer¿s implementation team and device specialist were onsite and aware of this even during go live day 2.The hospital risk manager reported that the hospital officially believes the patient expired from being critically ill.Another physician stated that although there was air in the right pulmonary artery, it was not substantial enough to cause a code.The patient received the bolus via our tubing from an intraosseous access in the leg.The patient also had an internal jugular (ij) access.Date of death was unknown.

Manufacturer Narrative

Although the end user did not keep the actual sample for this cause, they did return one (1) new 14687-15 primary plum set for inspection on (b)(6) 2022 where no visual damages or anomalies were noted.The complaint of air in line could not be confirmed on the received one (1) new 14687-15 primary plum set.The set was tested per product specification.There was no leakage.The product was attached to an icu medical provided iv bag, primed per packaging directions and a flow test was performed using an icu plum pump.No air in line alarms were generated and there were no air bubbles observed in the fluid path.Although a lot number was not reordered at the time of the event, the sample sent was for lot 6358729.The device lot history for this lot number was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Updated b2 b3 b5, b6, b7, d9 h3, h6.Product returned 12/22/2022.

Event Description

An update was received on 14dec2022 stated that the patient had a pre-existing condition of psychiatric/mental health and alcohol abuse and that the date of death was (b)(6) 2022.The risk manager from ascension health provided the following details ¿ io was placed in the right tibia and 1 l ns infused through io.Succinylcholine and etomidate given for intubation via io.Intubated very soon after arrival on (b)(6) 2022 at 2050.On the vent for 43 minutes when she coded.2111 labs of note: wbc 12.1, h/h 3/12, plt 84, pt 24.8, ptt 32, inr 2.3, na 135, k 2.8, co2 5, bun 24, ct 0.75, glucose 211, ast 270, alt 49, bili total 3.2, lipase 186, ammonia 137, lactic acid 34.7, ua yellow, turbid, ua ph 6.5, ua wbcs >100, uds negative, etoh 0.076, blood cultures resulted staph aureus.Right ij central line also placed by ed md and 2 ns boluses given by rns.Plum iv tubing appropriately flushed by both rns who administered ivf.Taken for ct chest and head.Cpr started on arrival back from ct at 2133.Multiple doses of epi given.Time of death called at 2200 by ed md.The me signed the death certificate.Official death certificate was requested to see what the official cause of death that was listed on the death certificate.Me declined jurisdiction and no autopsy was performed.Review by their physician shows "air does not appear to originate from the ij.Gas was in the inferior system.None in the svc.Nothing we determined in the natural death process for how the air got there." the ed supervisor states "pressure bag is a vyaire vital signs pressure infusor.The pressure bag, bag of ns, and the primary plum set were the items used connecting to the io for infusion.Ed supervisor added "this would have been the very first set we got in.We did not keep it.Further follow up was provided by our resource group "our icu primary tubing is a high volume item and turns over quickly.Unfortunately, we don't have any of the lot # of the primary tubing we received initially after the conversion.Additionally, i checked and lot #'s aren't added to our system in any phase to track them.We believe pt was on the cardiac monitor from soon after arrival and defibrillator during the code- as that is our normal process, however we do not have any strips saved from these devices¿.The date that the 14687-28 primary plum set was initially placed/used was on (b)(6) 2022.There were no issues noted during initial set-up/priming of the 14687-28 primary plum set.The iv tubing was discarded prior to the air being identified on ct scan.Ed supervisor states "there were no abnormalities noted from the equipment.It was inspected by the staff." the primary plum set was discarded.There were no digital photographs taken of the primary plum set nor the set-up mating/access devices.It was discarded prior to finding of air on ct scan¿ a second update was provided on 19dec2022 stating the cause of death base on the death certificate is complications of chronic alcoholism due to or as a consequence of.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• 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: 15965633
• MDR Text Key: 305326650
• Report Number: 9615050-2022-00317
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• 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: 11/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 14687-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• 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: CARDIAC MONITOR, MFR UNKNOWN.; DEFIBRILLATOR, MFR UNK.; EPINEPHRINE, MFR UNK.; PRESSURE BAG , VYAIRE.; UNSPECIFIED INFLATED PRESSURE BAG, MFR UNK
• Patient Outcome(s): Death