Model Number 2440-0600 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problems
Hyperglycemia (1905); Electrolyte Imbalance (2196); No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/29/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: non-bd extension set; non-bd stopcock; 500 baxter and exactamix ref (b)(4), lot number 1207056, exp 2019-12-31;10ml bd syringe ref (b)(4), lot number 6248559, exp 2019-08 normal saline, therapy date: (b)(6) 2017.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
|
|
Event Description
|
The customer reported that tpn (190ml) was initiated at 0200 at an unspecified rate.At 0500, the user noted the tpn was leaking onto the patient bed.Other separate infusions were lipids that was attached to a syringe set.
|
|
Manufacturer Narrative
|
The customer¿s report of a possible leak or free flow was not confirmed.Review of the pcu event log for the time period in question indicates that at 2:07 am on (b)(6) 2017 the pump module was programmed to infuse at a rate of 3.8 ml/hr with the vtbi set at 60 ml.The infusion continued until 6:52 am with patient side occlusions near the end of the infusion.The recorded total volume infused during the time period was approximately 17.5 ml.Following the first two occlusion alarms the log recorded a safety clamp open condition for approximately 8 seconds followed by a door open condition for 60 seconds, then another safety clamp open condition for 2 seconds, before the infusion was eventually restarted.During the 70 second period it is possible that a free flow condition was present if the roller clamp on the iv set was not closed.The set was visually inspected and no anomalies were observed.Functional and pressure testing resulted in fluid in the set flowing freely with no signs of leaking or occlusion.The root cause of the customer¿s report was not identified.
|
|
Event Description
|
The customer reported that at 0200 a 190 ml tpn bag was hung.Approximately 60ml was added to the burette and programmed to infuse at 3.8 ml/hr thru an umbilical line.At 0500, the user noted that the patient's bed was wet and the burette was empty.The nurse indicated that the fluid noted on the linen was either tpn or urine, and had a tpn odor.A bedside meter glucose level was checked with a reported (hhh) high reading.A serum sample was then sent for an actual value and confirmed hyperglycemia and hypercalcemia.There was no other medical intervention and the electrolytes and glucose levels normalized over time.The customer suspected that the set was leaking or a free flow event may have occurred.After the event the staff restored the setting on the device and it was confirmed that the rate was correctly programmed at 3.8 ml/hr.
|
|
Search Alerts/Recalls
|