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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MODULE SETS SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS PCA MODULE SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10800175
Device Problems Application Program Problem: Dose Calculation Error (1189); Excess Flow or Over-Infusion (1311)
Patient Problem Rash (2033)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 35ml monoject syringe, lot number: 10040650, exp: 06/11/2020. The report of an over infusion of morphine was confirmed. See complete investigation results in related reports 2016493-2020-01226 and 2016492-2020-02210. This report is being submitted to capture the incidental finding of a leaking tubing set, discovered during the investigation the provided pca micro bore tubing set model 10800175 was initially observed without cracks, tears, or indications of stress; however, during testing, the tubing presented a leak from the female luer. It is believed that the event tubing set, identified with a leak at the female luer, did not cause or notably contribute to the reported over infusion. The cause of the damaged luer is unknown. The root cause of the reported over infusion of morphine was determined to be a programming error. During programming, hydromorphone was selected in error, resulting in a pca dose delivery of 5 ml with each pca dose request, rather than the intended 1 ml. Device history: pca kit asv microbore cv model 10800175 (lot 19016325) was built among (b)(4) units on 18jan2019. There were no quality notifications issued during the production build of this set for the failure mode discovered.
 
Event Description
It was reported from the medical/surgical unit that patient controlled analgesia morphine in a 30ml syringe over infused with an intended dose of 1mg every 10 minutes, maximum dose of 6mg/hour lockout. , o basal rate, and no bolus dose. Syringe was initially replaced at 2125, which was double verified by 2 clinicians during dosage set up. At 2327 the nurse checked on the patient and saw that there was 6ml left in the syringe. The pump had delivered almost 24mg of morphine in 2 hours. Settings were verified again as mentioned above. The history in the pump was restored and its reading 0mg delivered, 0 attempts, and 0ml given as well as all categories appearing 0 as though the history had been cleared. Clinician denied clearing the pump other than when the new syringe had been placed. Lactated ringer was also infusing at the time of the event through another pump module. Although it was reported that there was no adverse effect caused to the patient and patient outcome was unaffected other than the rash and no additional intervention was done, it was reported that there was a change/delay in treatment due to that narcan and benadryl had to be administered as a result of this event.
 
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Brand NameALARIS PCA MODULE SETS
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
joyce muthama
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10335997
MDR Text Key203141199
Report Number9616066-2020-02324
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10800175
Device Catalogue Number10800175
Device Lot Number19016325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2019
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: 07/28/2020 Patient Sequence Number: 1
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