MAUDE Adverse Event Report: HALYARD ON-Q C-BLOC 400ML, 2.14ML/HR SAF+5ML/30MINONDEM; ELASTOMERIC PUMP

Model Number CB006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

Fill volume: 500ml, flow rate: 4ml/hr, procedure: total knee replacement, cathplace: popliteal nerve block.It was reported that a bolus device button would not latch.After surgery, the nurse primed and connected the pump to the patient.The nurse depressed the bolus button immediately after the pump as connected to the patient and it would not latch.The priming key did not break.The orange refill indicator was in the lowermost position on the bolus device.The pump was disconnected from the patient and a new pump was connected.No further incident occurred with the use of the replacement pump.It is unknown how long the nurse waited between priming and depressing the bolus button for the first time.It was discovered that the pumps were not always being primed in the pharmacy and the nursing staff would sometimes assume that the pump was being primed before use.It was reported that the device was discarded.No patient injury occurred.

Manufacturer Narrative

Method: the evaluation of the device is not available as the device is reported as discarded.A review of the device history record (dhr) was conducted.Results: as the device is unavailable for analysis, no device evaluation can be performed.For this reason results cannot be obtained.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related non conformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.The technical bulletin (1303554c) indicates, "it is important to prime the catheter prior to connecting it to the on-q with on demand pump to ensure the catheter is patent (free from occlusions)." "bolus activation.The patient or clinician should give a bolus as soon as possible after the infusion has started to ensure the bolus device is working properly.The bolus button should pop back up within a few minutes and the orange indicator (fig a) should be in the lower most position." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.The hospital pharmacy reported that an on-q representative went to the facility and re-educated staff on use of the pump and priming technique.It was reported that the hospital discovered that the pumps were not always being primed in the pharmacy and the nursing staff would sometimes assume that the pump was being primed before use.It was reported that there have been no further issues with the pumps since the re-education.No patient injury occurred in connection with the reported incident.

• Brand Name: ON-Q C-BLOC 400ML, 2.14ML/HR SAF+5ML/30MINONDEM
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4425972
• MDR Text Key: 5413468
• Report Number: 2026095-2015-00005
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/16/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: CB006
• Device Catalogue Number: 101347400
• Device Lot Number: 0201146974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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: T-BLOC CATHETER (I-FLOW); 0.2% ROPIVACAINE
• Patient Age: 60 YR
• Patient Weight: 86