MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problem Headache (1880)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record for the reported lot number, 0202372665, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The product involved in the report has been returned and is being processed for evaluation.Upon completion of the sample evaluation and the investigation; a follow-up report will be filed.All information reasonably known as of 21-feb-2018, has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the first of two reports.Refer to 2026095-2018-00020 for the second event.Fill volume: 500 ml.Flow rate: 6ml/hr.Procedure: ankle surgery.Start time: (b)(6) 2018.Stop time: (b)(6) 2018 at 4:38pm.It was reported that two pumps were used on a patient for ankle surgery.About 24-hours later, the patient started to have a terrible headache that would not go away.After two hours of being instructed to turn the pump's dial to "0", the patient's headache went away.The patient was instructed by anesthesia to remove the pumps.According to the patient of the pumps was almost empty.

Manufacturer Narrative

One (1) pump was received empty.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.After opening the pinch clamp infusion was observed at all selectable rates.Flow accuracy testing was performed with the selected-a-flow (saf) set to 6ml/hr.The pump was allowed to infuse for 50-hours and had a flow rate of 5.08ml/hr which was within specification with a +/-20% tolerance.Pressure pot testing was performed on the flow control tubing saf unit flow rates 2, 4, 8 and 14ml/hr.The saf unit was detached from the pump and hooked onto a pressure gauge and the filter was removed from the tubing.The average bladder pressure used was 8.16psi.Flow rate 2ml/hr yielded a rate of 2.04ml/hr which was within specification with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.98ml/hr, which was within specification with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.74ml/hr, which was within specification with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.66ml/hr, which was within specification with a +/- 20% tolerance.The investigation summary for the pump concluded that a fast flow was not observed on the pump.After refilling the pump to nominal volume it infused at all selectable rates.Flow accuracy testing was performed and was within specification with a +/-20% tolerance.Pressure pot testing also passed specification with a +/-20% tolerance.All information reasonably known as of (b)(6) 2018, has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(6).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7288919
• MDR Text Key: 101016214
• Report Number: 2026095-2018-00019
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202372665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/10/2018
• Patient Sequence Number: 1
• Treatment: 0.2% ROPIVICAINE; UNKNOWN ORAL MEDICATION
• Patient Age: 25 YR
• Patient Weight: 82