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Model Number 2420-0007
Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)
Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908)
Event Date 03/13/2019
Event Type  Death  
Manufacturer Narrative
The customer complaint that a programmed infusion infused faster than expected at an erratic rate was confirmed. Physical inspection showed no anomalies. The customer reported that pump module s/n (b)(4) infused norepinephrine faster than expected at an erratic rate. Log review began at approximately 1:00 am on the day of the event when the user reported that they observed an erratic infusion rate. Initial programming of the drug norepinephrine (8 mg/250 ml) using drug id
435 was programmed prior to the earliest date in the pcu event logs ((b)(6) 2019 4:14:33 am). On (b)(6) 2019 at 1:05 am the user changed the norepinephrine infusion dose to 0. 5 mcg/min which made the rate 0. 9375 ml/hr (0. 94 ml/hr). A few seconds later the infusion program was started and began infusing at a rate of 0. 9375 ml/hr (0. 94 ml/hr) with a vtbi of 204. 127 ml. At 2:14 am the user paused and restarted the device 38 seconds later. At 2:18 am the pump module was powered off and at 2:24 am was removed from the alaris system. Rate accuracy testing showed no anomalies. Dimensional analysis of the customer¿s disposable set silicone segment was performed. The silicone segment was found to be significantly more eccentric (out of round) with the wall thickness (max/min) out of specification. Non-uniform wall thickness can lead to non-uniform tubing collapse and orientation of the wall thickness uniformity can contribute to a failure to fully occlude the line. The root cause of the customer¿s report of an over-infusion and unregulated flow was identified as due to an eccentric (out of round) silicone tubing of the pumping segment of the event disposable set.
Event Description
It was reported that norepinephrine (8 mcg / 250 ml bag, concentration of 32 mcg/ml) infused faster than expected at an erratic rate in the icu. The norepinephrine was titrated to effect via the proximal line of a central venous catheter. Two peripheral iv¿s and one triple lumen catheter were infusing a total of 5 solutions. At 0100 the expected dose of norepinephrine was at 2 mcg/min. The user observed an erratic infusion rate, and when paused or turned off, drops continued in the drip chamber. The user changed out the pump module, primed new tubing, and found no further issue with administering the norepinephrine infusion. Intermittent sodium phosphate 15 mmol was given via one of the flush lines at 0130. At the time of the event, the patient was having severe episodes of difficult to control hypertension, which were thought to be associated with the patient¿s underlying condition of traumatic brain injury. The episodes were later determined to be a result of the irregular norepinephrine rate. Once the pump and iv lines were changed, the issue resolved. At 0200 the user observed that the patient¿s mean arterial pressure (map) was more stable than at 0100. Also infusing were 4 other normal saline infusions, three via a triple lumen cvc, and one via a peripheral iv. Nitroglycerin was also infusing via an additional peripheral iv. Although the customer indicated that the patient¿s blood pressure became more stable and the issue was resolved once the pump and tubing was changed, they later reported the patient had expired. It was unclear if the event caused or contributed to the patient's demise. Based on the initial presentation, lack of [meaningful] improvement of the patient, and predicated on family's expressed quality of life indices, comfort care was provided until end of life. Received a copy of the customer's (b)(6) program report from (b)(6) which states, ¿alaris pump was observed to continue giving medication to patient despite the pump being paused or off. The medication was norepinephrine. The patient's blood pressure was very labile and this was potentially contributed due to the unrealized pump error, which caused constant bolusing of the medication. Once the alaris pump was switched and the iv lines were changed, the issue resolved. ".
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Manufacturer (Section D)
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
MDR Report Key8649197
MDR Text Key146334327
Report Number9616066-2019-01386
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 05/29/2019 Patient Sequence Number: 1
8015,(4)2420-0007,(4)8100, TD (B)(6) 2019