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

Model Number	B2-70071-D
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)
Health Effect - Clinical Codes	Chest Pain (1776); Pain (1994)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device is being investigated.
Event or Problem 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.
Additional 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 or Problem Description
This is the follow up report for the initially submitted mdr (3006575795-2018-00008).

• 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: 7207881
• Report Number: 3006575795-2018-00008
• Device Sequence Number: 16377088
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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: B2-70071-D
• Device Catalogue Number: B2-70071-D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 68