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	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the iv set.
Event or Problem Description
The user reported that an iv set leaking issue.The solution passed through the closed roller clamp on the secondary line."we have had a disaster here the past couple of days with our secondary tubing! probably half of our tubings are still pouring liquid through the tubing, and upon closer inspection it appears that if you roll the roller to a certain spot it closes the line, but if you roll it all the way up it releases the tube and flows again.So, we have had chemotherapy, steroids, saline, and all kinds of other meds pouring onto our counters and floors.We at first thought it was someone forgetting to clamp the tubes, but then today we really ket an eye on it and discovered the mess! i just wanted to let you know, and we're hoping that it was just one box of secondary tubes and not all we have in stock!!" no patient was injured or harmed in this case.
Additional Manufacturer Narrative
The user-reported issue was not confirmed.Zyno medical performed the investigation testing on two cases of unused administration sets from the same lot on 09/13/2017.The leaking issue was not duplicated, and the roller clamps functioned as expected within specification.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00120).

• 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: 6560039
• Report Number: 3006575795-2017-00120
• Device Sequence Number: 865164
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 05/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1