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

Model Number B2-70072-F

Device Problems Burst Container or Vessel (1074); Mechanical Problem (1384); Occlusion Within Device (1423); Obstruction of Flow (2423); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Zyno medical is unable to confirm the reported filter burst issue, as no sample was saved at the user facility.Thus, no testing can be performed to replicate this issue.

Event Description

The distributor reported a administration set filter burst issue received at a user facility to zyno medical on (b)(6) 2018: "we are having issues with the filter sets, particularly when we run etoposide ivs.The lines will not run, and some of them burst from apparent pressure from not being able to run through." the distributor also confirmed the model number to be "b2-70072-f".The complaint handling unit lead at zyno medical followed up with the distributor on 02/14/2018 to confirm if the tubing was clamped below the filter and the drug that was infused during the incident: "etoposide should work with our tubing's with filter sets.Do you know if the customer had the tubing clamped below the filter? or if any other drug besides saline was used before etoposide?".The customer care representative of distributor responded, "no.All clamps were open.It happens about halfway to three quarters of the way through a bag.We only use saline for our etoposides." on 02/16/2018, zyno medical received more information directly from a representative at the user facility that the infusion pump would alarm "occlusion" prior to the filter burst.The quality engineer at zyno medical advised the user facility to lower the occlusion setting on the pump, substitute with the b2-700xx-df120 filter sets, or look at the mixing method used for the drugs.The representative at the user facility opted to speak with a sales representative at the distributor on 02/19/2018.The sales representative was informed by a nurse at the user facility that "the sample was not saved".On 02/20/2018, a corporate contract administrator at the user facility contacted the sales representative regarding the interim solution: "in the interim, is there a tubing and or pump replacement that can be utilized, also are all 0.22 micron tubing sets typically universal.Will the zyno pump accept tubing sets from another vendor ?".The sales representative responded that "we cannot recommend any tubing replacements.Our filtered sets are either.22 microns, or 1.2 microns.Your choice of sets is completely dependent on the drugs and solutions that you are infusing.I would consult your own pharmacy managers to discern what sets are appropriate.Zyno tubing must always be used with zyno pumps, with no exclusions.Also, it is against all company policies to use any sets, primary or secondary sets that are not zyno manufactured sets, for use with a zyno pump.No other sets are allowed to be used in the zyno pumps.This is a standard across the infusion industry, pumps are proprietary, and only zyno sets are to be used with zyno pumps.Additionally, it is recommended that you not use zyno sets with any pumps other than zyno medical pumps." on 02/23/2018, the clinical supervisor at the user facility confirmed the patient status that "no one was hurt by the incident" and the model number as "ref# b2-70072-f".The date of the incident was reported as "(b)(6) 2018" and the solutions used were "etoposide, normal saline".The clinical supervisor also reported that no secondary set was connected the primary set during the infusion and the primary infusion was set at "600ml/hour".The description of incident provided by the clinical supervisor is "while infusion was running alarm sounded for occlusion, at which point the filter burst".No patient information was available.

Event Description

This is the third follow up report for the initially submitted mdr (3006575795-2018-00030).

Manufacturer Narrative

Correction: in the second mdr follow up report, it was noted that "on (b)(6) 2018 zyno medical has received a letter from fda regarding a filter issue of the device".The date entered was a typo.The date that zyno medical received a user facility reported mdr (2300200000-2018-8001) from fda regarding a filter issue of the device should be (b)(6) 2018.Subsequently on (b)(6) 2018 zyno medical received a letter from fda requesting more information.

Manufacturer Narrative

Corrections: mdr 3006575795-2018-00030 followup 3 submitted on 04/05/2018 was labeled incorrectly as the third follow-up.It should have been submitted as 3006575795-2018-00030 followup 2.On 04/19/2018, zyno medical sent out the response letter to the fda providing additional information.

Event Description

This is second follow up report for the initially submitted mdr (3006575795-2018-00030).

Manufacturer Narrative

Zyno medical received an investigation report from the contract supplier of the affected device on 01/29/2019.The reported "filter occlusion" could not be confirmed, because the actual device was not returned for investigation.The supplier determined that the reported issue was an isolated event after performing a review of qn's and customer complaints from one year period.

Event Description

This is the fourth follow up report for the initially submitted mdr (3006575795-2018-00030).

Manufacturer Narrative

Zyno medical is unable to confirm the reported filter burst issue, as no sample was saved at the user facility and no lot number was provided.Thus, no testing can be performed to replicate this issue.

Event Description

This is a follow-up for the initially filed mdr (3006575795-2018-00030).On 03/21/2018 zyno medical has received a letter from fda regarding a filter issue of the device.A user facility mdr report was provided to zyno ((b)(4)) with the following event description: "etoposide (vp16) was running on a pump for a patient.The pump was alarming, so the rn checked on the pump.Pump read occlusion, so that tubing was changed, and the drug started running again for some time.The pump alarmed for occlusion again, so the rn checked the filter on the tubing.The filter exploded, spilling etoposide or the chemo gown, goggles, iv pole, and floor.A chemo spill kit was used to clean the area.No harm came to the patient and treatment was eventually completed.The faulty administration sets were not saved due to the chemotherapy contamination." no lot# or expiration date information was available.No specific event date was provided based on the user facility mdr report.The affected device was not saved.No patient injury or harm was provided.

• 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
• MDR Report Key: 7299975
• MDR Text Key: 101397799
• Report Number: 3006575795-2018-00030
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• Combination Product (y/n): N
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1