• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET Back to Search Results
Model Number B2-70071-D
Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)
Patient Problems Chest Pain (1776); Pain (1994)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
The affected set was tested and was believed to not be the concern with the air-in-line and infusion rate issue regarding an infusion pump reported under mdr 3006575795-2018-00001. Apart from one crimp spot of tubing, which was believed to be stemmed from the closed roller clamp by the user facility, the primary set performed as intended with no issues that would lead to air-in-line issue. The complaint was reviewed and closed on (b)(6) 2018.
 
Event Description
This is the follow up report for the initially submitted mdr (3006575795-2018-00008).
 
Manufacturer Narrative
The affected device is being investigated.
 
Event Description
The initial reporter from the distributor facility called about a secondary line infusion rate issue of the device to zyno medical on (b)(6) 2018. The email from the initial reporter is as below: "below is the contact information for the nursing supervisor for the (b)(6) location that the patient incident we discussed occurred at. We picked up the pump from the account on (b)(6) and it was shipped to my attention in (b)(6). I did a quick bench test at the patient setting that were in the pump and the air in lice alarm functioned normally. I also have the set that was in the pump at the account so i'll send that along for the investigation. " the initial reporter provided the following event description from the nursing supervisor at the location of the event through email: "on (b)(6) 2018, we had a patient in our infusion room to receive adriamycin and cytoxan chemotherapy. A primary iv bag of normal saline 250ml was hung for patient. Patient was given premedications of aloxi and decadron in a 50ml secondary bag over 15 minutes. Patient was then given adriamycin iv push over 10 minutes via free flowing iv. At 1413, cytoxan 1070 mg (53. 5ml of drug) diluted in 250ml of normal saline was hung on a secondary line to run over 1 hour (rate 304ml/hr). Nurse verified that clamp was open on secondary tubing and that drug was dripping. At approximately 1500, patient complained of chest pain to rn who was walking by. Pump was stopped at this point and tubing was disconnected from patient. Patient was given rescue medications for possible reaction to drug and was placed on oxygen. Her vital signs were stable during this time. However, patient only noted minimal improvement in her symptoms. It was then noted that patient's secondary bag of cytoxan had not infused at all and that primary line of normal saline was completely empty and that there was a large amount of air in the tubing all the way to the patient. The zyno z-800 pump never alerted the staff that there was air in the line. Because patient was not improving, she was transported to (b)(6) er via paramedics. Zyno pump was pulled from use and representative from (b)(6) was contacted. Patient was worked up in the er, had ct scan and was cleared to go home. Her symptoms did eventually dissipate. " during the follow-up with the nurse supervisor initiated by the complaint handling specialist at zyno medical, it was confirmed that the medical center "does not make any adjustments to the pump settings other than programming rate and volume at the time of infusion" and that the secondary bag (filled with cytoxan) was hanged up higher than the primary bag. The patient was confirmed to be in stable condition as of (b)(6) 2018. Zyno medical also followed up with the nursing supervisor on (b)(6) 2018 about receiving the two administration sets involved in the event for investigation and obtained the following response: "we did not save the secondary set. However, we saved the bag of cytoxan on the day of the occurrence and infused it the next day without any issue or having to change the tubing on the secondary. " this pump involved in this incident was reported under mdr 3006575795-2018-00001. This mdr addresses the primary iv sets involved, which was returned to the manufacturer for evaluation on 01/09/2018.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
Type of DeviceIV 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 Key7207881
MDR Text Key253603476
Report Number3006575795-2018-00008
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70071-D
Device Catalogue NumberB2-70071-D
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-