MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Model Number	Z-800
Medical Device Problem Codes	Device Alarm System (1012); Defective Alarm (1014); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has not yet been returned to the distributor.
Event or Problem Description
On (b)(6) 2019 zyno medical received a missed occlusion alarm issue of infusion pump from a distributor representative.The distributor forwarded the information from a user facility representative: "pump serial # (b)(4) would not alarm occlusion even with clamp on tubing.No patient harmed.Noticed by rn.Medication simponi aria." no information on patient gender was received by zyno medical.The distributor also provided the last date of periodic maintenance of this device as 06/05/2017.
Additional Manufacturer Narrative
The reported occlusion alarm issue was not confirmed.Zyno medical received the test result on 06/21/2019 from the service provider.The affected device was tested on 06/13/2019 by the service provider and it alarmed within the specification of the 8psi and 30psi occlusion tests.The device was found to meet all specifications on 06/13/2019.
Event or Problem Description
This is a follow up report for the initially submitted mdr (3006575795-2019-00013).

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Common Device Name: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8674692
• Report Number: 3006575795-2019-00013
• Device Sequence Number: 2372791
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: Z-800
• Device Catalogue Number: Z-800
• Device Lot Number: 20130123-SH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 71