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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Therapeutic Response, Increased (2272)
Event Date 03/10/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that on an adult general care unit, a patient¿s infusion of heparin (2500 units/250 ml) was expected to infuse at 11 ml/hr and the bag was found empty earlier than expected at 1500. The vtbi was programmed from the previous shift, and the vi at the time of the event was unspecified. The heparin bag was changed in the morning, and was expected to continue to the following night shift (unspecified time). An ail alarm occurred earlier in the day and approximately 30 ml of volume was discarded during troubleshooting of the alarm. The nurse then manually counted the drip rate and noticed that pump appeared to be infusing faster than the programmed rate. The nurse removed the set from the module and inserted it into a different module. The drip rate still appeared to be faster than the programmed rate. The nurse obtained a new pump, and the set was installed into the new pump. The drip rate continued to appear to be faster than the programmed rate. The set was then changed which appeared to correct the infusion rate. After the event, the heparin was stopped for 60 minutes and the rate was decreased. A stat partial thromboplastin time (ptt) was ordered. At 19:00, value was greater than 140. At 7 am before the incident, the ptt was 94. Prior to the heparin infusion the patient received magnesium and thiamine. No other medications were infusing via the same pc unit at the time of the event. The event set was sequestered, the devices were not. No other effect to the patient was reported. Received a copy of the customer's (b)(6) program report from (b)(6) which states, ¿patient being treated for atrial fibrillation. Heparin infusion was running at 11ml/hr. Nurse calculated how many hours the heparin bag would last at the beginning of their shift. The bag was expected to last until the following night shift: however, the bag was found to be empty around 1500 hrs.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET,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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8485785
MDR Text Key141014671
Report Number9616066-2019-00878
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
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 Manufacturer04/18/2019
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: 04/05/2019 Patient Sequence Number: 1
Treatment
PRI TUBING,8100,(2)8015,8100, TD (B)(6) 2019
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