MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q C-BLOC 400ML, 5ML/HR + 5ML/60 MIN ONDEMAND; ELASTOMERIC PUMP

Model Number CB003

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

Fill volume: 400ml.Flow rate: 5ml/hr.Procedure: shoulder surgery.Cathplace: interscalene block left neck.It was reported that a pump with a pca button did not latch.The orange indicator on the bolus device was in the bottom position.The nurse noticed the reported incident while discharging the patient on (b)(6) 2015.The nurse reported it as, "pump bolus dose given when pump attached without difficulty; blue button clicked backup - approx.1-1/2 hr later during d/c instruction with family - rn attempted to demonstrate how bolus dose is given and the blue button was springy would not reengage - noted that yellow line was not back up to indicate that bolus chamber had refilled - aa notified and pump removed and replaced with new pump." additional information was received on (b)(6) 2015.It was reported that there was no adverse event that occurred due to the reported incident.The patient's condition was reported to be within normal limits (wnl).

Manufacturer Narrative

(b)(4).Method: the device was received for analysis.A visual inspection and a review of the device history record (dhr) were conducted.Results: there are no testing results available as the investigation and evaluation are currently in progress.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Manufacturer Narrative

Method: along with the previously reported methods, a microscopic inspection was performed.Results: a visual inspection found the pump returned empty.The orange fill indicator was in the top position with the patient controlled analgesia (pca) button down.The distal luer cap was on the distal luer.During visual analysis the tip of the pca prime key was found remaining in the pca device.Conclusions: based on the analysis, the break on the pca prime key tip and the damage to the opening where the prime key is inserted into the pca device, indicated that the prime key was improperly removed.The instructions for use (ifu) specifies, "remove the on demand device red tab by pulling straight out (figure b).It is important to remove red tab completely and ensure it does not break (figure c).The ondemand* bolus device will begin to fill.Warning: do not pull the red tab upwards as breakage could occur (figure c)." as previously reported the dhr review indicated that the lot met the process specifications, including the quality control acceptance criteria prior to release.A capa was initiated to address the broken prime key inside the pca device.An ifu (14-60-611-0-04) was sent to the customer.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q C-BLOC 400ML, 5ML/HR + 5ML/60 MIN ONDEMAND
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD-IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discover; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4638845
• MDR Text Key: 5599973
• Report Number: 2026095-2015-00113
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2016
• Device Model Number: CB003
• Device Catalogue Number: 101347100
• Device Lot Number: 0201605261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTIPLEX CATHETER; NAROPIN 0.2%
• Patient Age: 67 YR
• Patient Weight: 110