MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

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.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6699240
• MDR Text Key: 79583167
• Report Number: 9616066-2017-01012
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-0600
• Device Catalogue Number: 2440-0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 4 DA
• Patient Weight: 1