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

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.

• 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 Key: 7656417
• MDR Text Key: 112993327
• Report Number: 9616066-2018-00972
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• 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 Date: 08/01/2018
• Device Model Number: 30893
• Device Catalogue Number: 30893
• Device Lot Number: 15086251
• Other Device ID Number: 10885403273964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8120,8015,SYRINGE, THERAPY DATE (B)(6) 2018
• Patient Outcome(s): Required Intervention
• Patient Weight: 23