MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,600X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB6004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Incontinence (1928); Nausea (1970); Numbness (2415); Constipation (3274)

Event Date 04/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # unknown.The actual complaint product was not returned for evaluation the device history record for the reported lot number, 0202342914, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.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

Fill volume: 750ml, flow rate: 2-8 ml, procedure: left arm surgery, cathplace: left neck/chest area.A report was received stating the patient had an alleged reaction and experienced bladder incontinence, nausea, jittering, constipation, and numbness to patient's arm.Patient called the product support line nurse because she was experiencing some side effects of the local anesthetic.They noticed that the pump was not infusing due to pain on saturday around 11:00am., and the patient noticed the white clamp was closed.The patient opened it and the pump was already preset at 8ml/hr.At 5:00pm on saturday the patient turned it down to 6ml/hr due to bladder incontinence and at 10:00pm to 4ml/hr.The patient called at 10:00pm.And stated that she was nauseated and jittery.The patient was wondering if that could also be a side effect of the medication.The product support line nurse explained that the nausea and jitteriness was not necessarily a side effect of the local anesthetic.The product support line nurse recommended that the patient clamp the pump for an hour to one hour and a half.The nurse hotline also recommended the patient call the anesthesiologist.The patient said that she will try the pump at 4ml/hr for a while and then turn it to 2ml/hr if necessary.The product support line nurse called the patient at 11:30 pm on saturday night.The flow rate was decreased to 2ml/hr.The patient's incontinence had resolved, but her arm was still numb and she felt constipated.The product support line nurse recommended keeping the pump at 2ml/hr overnight.Additional information received 02-may-2016 noted the patient is currently doing well.All of the patient's symptoms of numbness to her arm, headache, nausea, incontinence, and jittering had been resolved.The pump was still infusing and has not been completed as of yet.The flow rate at that time was currently at 6 ml/hr.The patient had been titrating it from 2-8 ml for comfort level.The patient did not know when the infusion was to end.At this time, the pump was still half full.The patient had received anesthetics in the past and had not had any issues.The patient's pain level at this time was manageable.No further information to be provided.

Manufacturer Narrative

One used sample was returned.The pump was returned partially full.The pinch clamp was opened and the pump infused at all selectable rates.The tubing was cut 2 inches distal to the blue connector to drain the medication.The pump 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 600ml.The flow accuracy test was performed with the saf set to 8ml/hr.After 56.25 hours of testing, the pump yielded a flow rate of 6.65ml/hr which is within specifications with a +/- 20% tolerance.The pressure pot was performed on the selected-a-flow unit flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge.The average bladder pressure used was 6.72psi.The saf flow rate 2ml/hr yielded a flow rate of 2.02ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.90ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.81ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 10.21ml/hr which is within specifications with a +/- 20% tolerance.The investigation summary concluded that fast flow was not observed.During the flow accuracy test, the pump flow rate was within specifications.During pressure pot testing, all flow rates met specifications using the average bladder pressure.The root cause is unknown.The use review concluded that the medications, ropivacaine and ativan, could have contributed to the reaction incident, but it is not possible to determine conclusively if those medications were the actual cause.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).

• Brand Name: SURGPN,600X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5676363
• MDR Text Key: 45813930
• Report Number: 2026095-2016-00052
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: CB6004
• Device Catalogue Number: 101347602
• Device Lot Number: 0202342914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 50