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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 2420-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Burning Sensation (2146)
Event Date 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
The customer¿s reported complaint of an over infusion of potassium was not confirmed during the investigation while testing the source device and returned tubing set. Based on the logs, the reported incident occurred between 6:43 pm ¿ 6:54 pm on (b)(6) 2019. An infusion of 100mls of potassium was programmed at a rate of 50ml/h and stopped prematurely after approximately 10 minutes. The total volume infused was recorded at 9. 216mls. Test results confirmed the unit passing a timed rate accuracy test utilizing customer¿s returned pcu, the incident programmed parameters and the returned incident administration set. Results demonstrated the device was in specification and operating as intended. Although the silicone segment was found to be marginally out of specification, it was not believed that this contributed to the reported event. The root cause of the customer¿s experience with an over infusion was not definitively identified during the investigation.
 
Event Description
It was reported that a patient arrived to ed with a cerebral bleed and hypokalemia (2. 2mmol/l). The rn initiated a potassium infusion ( 20 meq/100ml) programmed at a rate of 50ml/hr. For 2 hrs. , and observed the flow from the drip chamber for a few minutes prior to leaving the patient. Approximately 10 minutes later, the patient complained of burning to his arm and noticed the drug rapidly dripping from the drip chamber. The infusion was quickly stopped, and devices sequestered.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INFUSION
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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8895387
MDR Text Key154436714
Report Number9616066-2019-02310
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19045580
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/05/2019
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: 08/14/2019 Patient Sequence Number: 1
Treatment
8015, 8100, THERAPY DATE (B)(6) 2019
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