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

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problem Muscle Weakness (1967)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device is reported to be available but has not been returned.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 31-aug-2017 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)(4).

Event Description

Fill volume: unknown.Flow rate: 8ml/hr to 10ml/hr.Procedure: unknown.Cathplace: unknown.It was reported that the pump was turned up from 8ml/hr to 10mlhr last night and the clinicians felt infusion flowed in rapidly and emptied.The clinician's said the patient had quad weakness.Furthermore, an under ultrasound was performed and "it seemed like there was a large deposit of medication in the muscle." no additional information was provided.

Manufacturer Narrative

The device history record for the reported lot number,0202671964, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The pump was received partially full with a green stingray and catheter.Infusion was verified on all the flow rates and it flowed, except 0ml/hr.The tubing was cut a few inches distal to the blue connector to drain the medication.The tubing was bonded back together with a male and female luer using cyclohexanone.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 400ml.The flow accuracy test was performed with the select-a-flow (saf) set to 10ml/hr.After 30 hours of testing, the pump yielded a flow rate of 5.53ml/hr, which is below specifications with a +/-15% tolerance.The flow rate was off by 2.47ml/hr from the passing rate of 8.00ml/hr.The pressure pot was performed on the flow control tubing (select-a-flow unit) on flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The tubing was detached from the pump and connected to a pressure gauge.The average bladder pressure used was 8.86psi.Flow rate 2ml/hr yielded a flow rate of 2.03ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.37ml/hr which is which is within specifications with a +/-20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.12ml/hr which is within specifications with a +/-20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.84ml/hr which is within specifications with a +/-20% tolerance.The investigation summary concluded that a fast flow was not observed for the pump.During the flow accuracy test, the pump was below specifications.During pressure pot testing, the saf met specifications.All information reasonably known as of 9-nov-2017 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)(4).

Manufacturer Narrative

All information reasonably known as of 26-sep-2017 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)(4).

Event Description

Additional information received 01-sep-2017 stated, "basically the patient had quad weakness and assumed that the on-q was running too fast.It was reported that the device emptied into the patient but when the device was retrieved by the company representative the pump was half full.The patients quad weakness did not resolve until monday, seven days after surgery." no further information was provided.

• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6837217
• MDR Text Key: 86100079
• Report Number: 2026095-2017-00154
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2017

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: Nurse
• Device Expiration Date: 09/20/2017
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0202671964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 09/01/2017; 10/23/2017
• Supplement Dates FDA Received: 09/26/2017; 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• Type of Device Usage: N
• Patient Sequence Number: 1