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

Model Number	CB6004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the actual device was not returned.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.All information reasonably known as of 17-apr-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).
Event or Problem Description
Fill volume: 750 ml, flow rate: 8-6 ml/hr, procedure: rotator cuff surgery, cathplace: neck.It was reported that a patient who had rotator cuff surgery had an elastomeric pump with a flow rate that was initially set to 8 ml/hr after the surgery.However, the patient experienced shortness of breath.It was recommended by the anesthesiologist that the flow rate of the pump be decreased to 6 ml/hr.Two hours after adjusting the flow rate, the patient reported that he felt better.The pump's use was continued until (b)(6) 2017.
Additional Manufacturer Narrative
All information reasonably known as of 05-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 or Problem Description
Additional information received on 11-apr-2017 from the reporter in the anesthesia department stated he fielded it and put it in.It was noted as working great, but he was unsure of the malfunction.The catheter came out of the snaplock adapter and was no longer sterile, so it was removed.The reporter noted that the sample was not available, but it was not a halyard health catheter or adapter.

• Brand Name: HYHSURGPN,600X2-14,CB SAF,-,OQ,5
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6503346
• Report Number: 2026095-2017-00061
• Device Sequence Number: 14725
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2019
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0202577830
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/06/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE 0.2%
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 86