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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

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ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET Back to Search Results
Model Number A2-80075
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 01/24/2017
Event Type  malfunction  
Manufacturer Narrative
One zyno customer service employee followed up with the user over the phone. The user reported that when he primed any of the carefusion primary set, it leaked at the luer lock. The zyno employee explained that sometimes during priming, fluid can be stored in the luer lock if the luer lock cover is on. The zyno employee advised the user that the luer lock cover could be taken off before priming the set in the future. Alternatively, the user can leave the cover on, and when he primes the carefusion set, he should pay attention to the luer lock and stop priming when he sees that the set is fully primed. The user also reported that when he closed the roller clamp on the secondary set, it doesn't stop the fluid and caused a leak. The zyno employee asked the user to send any fields set that are available back to zyno to initiate the evaluation, but was informed that no sets were saved. The user was advised to contact zyno's territory manager if future issue arise and save the samples for evaluation. The model number reported by the customer was b2-80075 with lot # 1053035ks. As zyno medical does not carry a product with model number b2-80075 and the model number associated with lot # 1053035ks should be a2-80075, this mdr is filed towards the iv set with the model number of a2-80075 and the correction has been made.
 
Event Description
The user reported that they were "having an issue with the tubing sets leaking even though they are clamped" and "they are leaking before getting to the pumps". He also reported that "this is happening with all three sets that we use" and he has "closed all clamps on the primary lines and it still leaks". No patients were involved and various medications were used.
 
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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 Key6329912
MDR Text Key67399427
Report Number3006575795-2017-00040
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
Report Date 02/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2-80075
Device Lot Number1053035KS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2017
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

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