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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 30893
Device Problem Fluid/Blood Leak (1250)
Patient Problems Inadequate Pain Relief (2388); Underdose (2542)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported fluid leaked from the pca set during an epidural infusion of fentanyl/bupivacaine at 5 ml/hr.The patient experienced uncontrolled pain because of the leak and was given oxycodone 5 mg and ibuprofen 200 mg orally.There was no report of long term patient harm.Received a copy of the customer's medsun report from fda, which states: "the patient had a pca epidural after surgery and woke up with pain out of control.After checking dermatome levels, it was discovered she was not numb at all from the epidural (change from earlier checks).Further inspection of the line revealed leakage where the tubing transitioned into a hub.The hub then connected to the filter.The tubing on the epidural was changed out." an incomplete date of event of (b)(6) 2018 was provided.
 
Manufacturer Narrative
The customer¿s report that fluid leaked from the pca set was confirmed.Visual inspection showed no anomalies or damage on the set or its components.Examination under magnification revealed some solvent channels at the exterior tubing and interior male luer surfaces that seemed more evident along the area of the yellow stripe of the microbore tubing.Functional testing confirmed leaking at the engagement of the tubing to male luer adapter.The root cause was not identified.
 
Event Description
The customer reported fluid leaked from the pca set during an epidural infusion of fentanyl/bupivacaine at 5 ml/hr.The patient experienced uncontrolled pain because of the leak and was given oxycodone 5 mg and ibuprofen 200 mg orally.There was no report of long term patient harm.Received a copy of the customer's medsun report from fda, which states: "the patient had a pca epidural after surgery and woke up with pain out of control.After checking dermatome levels, it was discovered she was not numb at all from the epidural (change from earlier checks).Further inspection of the line revealed leakage where the tubing transitioned into a hub.The hub then connected to the filter.The tubing on the epidural was changed out." an incomplete date of event of (b)(6) 2018 was provided.
 
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Brand Name
ALARIS PCA MODULE SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7656417
MDR Text Key112993327
Report Number9616066-2018-00972
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K811885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2018
Device Model Number30893
Device Catalogue Number30893
Device Lot Number15086251
Other Device ID Number10885403273964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2018
Initial Date Manufacturer Received 06/11/2018
Initial Date FDA Received07/02/2018
Supplement Dates Manufacturer Received06/11/2018
Supplement Dates FDA Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8120,8015,SYRINGE, THERAPY DATE (B)(6) 2018
Patient Outcome(s) Required Intervention;
Patient Weight23
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