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

Model Number CB6004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Nausea (1970); Vomiting (2144); Dizziness (2194); Urticaria (2278); Reaction (2414); Lethargy (2560)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).There is no information provided regarding the return of the actual complaint product to the manufacturer.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.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).Device not returned.

Event Description

Fill volume: 700 ml, flow rate: 6 ml/hr, procedure: rotator cuff repair, cathplace: neck, date of procedure: (b)(6) 2017.It was reported a patient had surgery on (b)(6) 2017, and post-surgery, the patient woke up to feel her throat in pain in conjunction with difficulty breathing.The hospital staff advised that this was part of the recovery and the issue would resolve in time.The patient was discharged with the elastomeric infusion pump, and the next morning, her face and body was covered in hives.She also experienced a shortness of breath.The patient's husband took her to the emergency room (er), and while en-route to the er, she tried to adjust the select-a-flow (saf) dial to 0, but the dial broke.The pump was clamp upon arriving to the er, and symptoms began to improve two hours after clamping.The er staff advised that she was experiencing an allergic reaction, which could possibly be from the medication in the elastomeric infusion pump.As a result, she received antihistamines (benadryl), and fluid therapy to flush her system out.The pump was not labelled with type of medication it contained.Additional information received on 16-mar-2017 stated that it was believed that she had an allergic reaction to either the oral pain medication or the antibiotics she received.Additional information received on 17-mar-2017 stated that the only medication the patient received during infusion was motrin 800 mg.It was noted that the patient received motrin in the past and experienced no adverse reactions to it.It was unknown if the patient received any additional medications pre-operatively or intra-operatively.No further information was provided.

Manufacturer Narrative

All information reasonably known as of 15-may-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 provided additional symptoms experienced by the patient during the emergency room admission; nausea, vomiting, drowsiness, and dizziness.

Manufacturer Narrative

All information reasonably known as of 09-jun-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.(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 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: 6419169
• MDR Text Key: 70417407
• Report Number: 2026095-2017-00046
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: CB6004
• Device Catalogue Number: 101347600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/16/2017; 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MOTRIN 800 MG
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR