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

Model Number	30883
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Received a copy of the customer's additional information request letter from the fda which states, "the patient had a midline iv.The patient also had an epidural for pain control post-op back surgery.Pca tubing used to have colored lines on them.For the iv pca there was a blue line down the tubing.For epidural pca there was a yellow line down the tubing.However, currently there is no colored lines down the tubing at all.Nursing has stated they used those colored lines as a helpful cue as to where to infuse the pump.Postoperatively, the patient was ordered to have fentanyl 2 mcg/bupivacaine 0.125% infusion into his epidural on a pca pump.The pump was connected to the patient's iv rather than to the patient's epidural.Approximately, eight hours later when the syringe was due to be changed in the pump, it was noted.The pump was stopped immediately and the provider was called.No noted detrimental effects to the patient including; no change in vital signs.I have asked our supply chain manager to inform the company of this event".
Additional Manufacturer Narrative
Product expiration date (b)(6) 2021.Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
Event or Problem Description
The patient was post-operative from back surgeries.Nursing had thought the epidural infusion was iv tubing, and attached the epidural tubing to the patient's midline.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s complaint that the tubing intended for epidural use was connected to iv could not be confirmed because the product was not returned for failure investigation.A photo of a pca administration set model 30883 was provided by the customer.No issues were observed during visual inspection.The root cause of this failure was not identified.
Event or Problem Description
Received a copy of the customer's additional information request letter from the fda which states, "the patient had a midline iv.The patient also had an epidural for pain control post-op back surgery.Pca tubing used to have colored lines on them.For the iv pca there was a blue line down the tubing.For epidural pca there was a yellow line down the tubing.However, currently there is no colored lines down the tubing at all.Nursing has stated they used those colored lines as a helpful cue as to where to infuse the pump.Postoperatively, the patient was ordered to have fentanyl 2 mcg/bupivacaine 0.125% infusion into his epidural on a pca pump.The pump was connected to the patient's iv rather than to the patient's epidural.Approximately, eight hours later when the syringe was due to be changed in the pump, it was noted.The pump was stopped immediately and the provider was called.No noted detrimental effects to the patient including; no change in vital signs.I have asked our supply chain manager to inform the company of this event." the patient was post-operative from back surgeries.Nursing had thought the epidural infusion was iv tubing, and attached the epidural tubing to the patient's midline.There was no patient harm.

• Brand Name: ALARIS PCA MODULE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8701902
• Report Number: 9616066-2019-01515
• Device Sequence Number: 11220364
• Product Code: FPA
• UDI-Device Identifier: 10885403273957
• UDI-Public: 10885403273957
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 30883
• Device Catalogue Number: 30883
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/11/2019; 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8120,8015,MIDLINE,SYRINGE
• Patient Age: 55 YR
• Patient Weight: 125