MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP; IV ADMINISTRATION SET

Model Number	B2-70072
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The received device is being sent to the contract supplier for investigation.Zyno medical is meanwhile actively following up with the customer regarding the nature this complaint.
Event or Problem Description
Zyno medical received the device from the user on (b)(6) 2017.The customer service representative at zyno medical contacted the user on (b)(6) 2017 and the user reported that this device was the affected device from mdr 3006575795-2017-00268_complaint (b)(4).Zyno medical communicated with the user stating that the device received was a used primary administration set.This primary set was connected to a 5% dextrose solution bag while also attached to a secondary administration set with a solution of 0.9% sodium chloride with diphenhydramine.Neither of the received administration sets matches the description of the affected device in complaint (b)(4).Zyno medical is still in the process of contacting the customer regarding the complaint nature of the received device.No patient injury or harm was reported and no event date was provided by the user.
Additional Manufacturer Narrative
On 12/12/2017, zyno medical received the investigation report from the contract supplier of the affected device.No failure was found with the device during the functional testing, and thus no root cause of the complaint was found.Further details of the investigation results can be found in the report attached.The user-reported "unknown issue" could not be confirmed.Zyno medical attempted to follow-up with the customer on 10/12/2017, 10/16/2017 and 10/23/2017 with no response received from the customer.On 10/31/2017, a representative at the customer site replied with the following message: "at this point, i have lost track of what tubing were sent and what the issues were.We are currently creating a form for each site to fill out to accompany any returned items to vendors.The site will keep a copy for reference.Hopefully this will prevnt this type of confusion going forward." (b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-00290).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 6996353
• Report Number: 3006575795-2017-00290
• Device Sequence Number: 11087512
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: MH
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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
• Operator of Device: Health Professional
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 17052349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1