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Model Number 2420-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 03/12/2019
Event Type  Injury  
Manufacturer Narrative
The customer¿s report of an overinfusion and unregulated flow was confirmed. An ¿as-received¿ inspection was performed on the received pump module and disposable set. No anomalies were observed. The pcu event log shows pump module s/n (b)(4) was programmed to infuse drug id (b)(6) at a rate of 5. 63ml/hr with a vtbi of 240ml at 10:06 am on (b)(6) 2019. At 10:08 am, the infusion was paused and then restarted at 10:10 am. One second later the infusion was paused again. At 10:14 am, the user programmed a delay for 45 minutes. At 10:59 am, the system alarms for callback before infusion. At 9:20 am on (b)(6) 2019, the device is channeled off and the system is shutdown and powered off. The volume recorded as being infused during this period was 0. 112ml. Unregulated flow was observed on pump module s/n (b)(4) with the returned primary set (model 2420-0007) during a site visit. The pump module was evaluated during the site visit and no anomalies were observed during disassembly and inspection. The event disposable set was evaluated and found to be eccentric (out of round). Rate accuracy testing performed shows this non-concentricity (between inside diameter (id) and outside diameter (od) to have a direct impact on the rate accuracy performance. The root cause of the customer¿s report of an overinfusion 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 an over-infusion of norepinephrine occurred in the icu. Norepinephrine 32 mcg/ml (8 mcg/ 250 ml) was initiated via a central line to regulate the patient's blood pressure if below the map goal of 60. The map was 48 at the time and the sbp was 90 mmhg; norepinephrine was begun at 3 mcg/min (5. 6 ml/hr). Upon starting the infusion, the patient was monitored for clinical response to the medication, and noted the drip rate for the norepinephrine infusion was faster than the programmed rate. The pump was paused however the medication continued to free flow, bolusing the patient. During the event, the patient¿s systolic blood pressure (sbp) spiked above 250 mmhg. Labetalol 15 mg iv was administered to lower the systolic blood pressure. The patient was then monitored closely with no further adverse effects. Also infusing at the time were normal saline as an access line on a different pump (typically 10 ml/hr) and possibly albumin via gravity (started at 09:00). The nurse disconnected the medication line from the patient ; the unit educator and charge nurse were notified. The devices and tubing were sent intact to biomed for investigation. Received a copy of the customer's cmdsnet program report from health canada which states, ¿norepinephrine infusion was started via a central line to regulate patient low blood pressure below map goal of 60 (map 48), sbp was 90 mmhg at the time. Medication was programmed into the pump as 3 mcg/min (5. Ml/hr). Nurse noticed that chamber drip rate was faster than programmed rate, the pump was paused but medication continued to free flow blousing the patient. Nurse disconnected the medication line from patient and notified unit educator and charge nurse. Intervention was required to correct the patient's blood pressure. Patient was monitored closely with no further apparent adverse effects. Video was taken of the pump free flowing the medication when roller clamp was open with the pump paused. Door of pump was looked at and determined to be properly closed. ".
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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 Key8648412
MDR Text Key146333665
Report Number9616066-2019-01266
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 foreign,health professional,o
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/28/2019 Patient Sequence Number: 1