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

Model Number AA-80075

Device Problems Device Operates Differently Than Expected (2913); Free or Unrestricted Flow (2945)

Patient Problem Not Applicable (3189)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

The affected iv set was not saved by the user and thus the reported issue could not be confirmed.Device not returned.

Event Description

The user reported an issue with the iv set roller clamp."we have been having an issue with some of our secondary tubing.The blue clamp, when rolled down to the closed position, is still allowing fluid to pass.We started noticing this last week.It was noticed by our technicians when attaching the tubing to an ivpb.It isn't happening every time, only occasionally.We started to notice this on (b)(6)2017 and it has happened on several occasions since then.We did not keep the iv set but will do so if we run across another." the solution used was saline when the issue was observed.No patient was involved in this case.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 6690549
• MDR Text Key: 79181527
• Report Number: 3006575795-2017-00238
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020600
• UDI-Public: 00814371020600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA-80075
• Device Lot Number: 107272KS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1