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

Model Number	AA-80075
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently waiting for the arrival of the set.
Event or Problem Description
On (b)(6) the user reported fluid leaking issue with administration sets."we have had several more cases of this same problem.We kept one of the tubing sets.Unfortunately the other one was contaminated with hazardous drug and we had to dispose of it." the nurse used 1000ml ivpb normal saline, and (b)(6)2017 was the date that the ivpb made it to the nurse."technically the patient was not involved.The mediation was made and sent to the nurse.Before administering the medication she noticed that fluid was leaking into the chemo bag that contained the ivpb.It was noticed that the clamp was closed and fluid was still leaking.We have also had this happen on several occasions when we spike the bag before medication is added." no patient injury or harm occurred for this case.
Additional Manufacturer Narrative
The user reported leaking issue was confirmed.Zyno medical has received the investigation report from the contract supplier amsino international, inc on 01/12/2018.The root cause of issue is found to be the deformation of the roller occured during the assembling process.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00244).

• 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: 6725213
• Report Number: 3006575795-2017-00244
• Device Sequence Number: 13624487
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,study
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: AA-80075
• Device Lot Number: 109233KS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1