Model Number B2-70071-DF |
Device Problems
Improper Chemical Reaction (2952); Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Patient Problem/Medical Problem (2688)
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Event Type
malfunction
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Manufacturer Narrative
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From the investigations performed relating to this complaint up to 11/19/2019, zyno medical currently has the following understanding: no issues have been identified for the zyno administration sets regarding to design or manufacturing.The previous recall on the b2-70071-df model mentioned by the customer was related to a potential filter leaking issue which has been corrected.It is unlikely that a filter leaking issue could cause patient reaction as reported by the customer.Both medications mentioned in the complaint, taxol and opdivo, can cause reactions in patients, and this is well documented in drug information sheets from fda website (please see attachment 2 - opdivo (nivoiumab) injection review report and attachment 3 - taxol (paclitaxel) injection review report).The customer opened the sets 1-2 days prior to use and stored them in the cardboard box, which compromised the sterility of the sets.This may have contributed to the issue in the complaint.(please see attachment 4 - response from the user facility about the storage practice of sets).None of other customers using zyno medical administration sets has complained the same or similar issue, which confirms that there is no systematic defect of the device that could cause the reported issue.A capa request about the reported issue was submitted on 11/15/2019, and the capa board meetings were held on 11/18/2019 and 11/19/2019.The capa board members performed risk analysis for the nonconformance following zyno medical failure modes and effects analysis (fmea) work instruction (023-wi-003, rev b).The severity rating is determined as 3 - moderate, the occurence rating is determined as 1 - improbable, and the detection rating is determined as 5 - remote probability of detecting the failure before it occurs.Thus, the risk priority number (rpn) = 3*1*5 = 15, which is within the low risk range according to the fmea work instruction.The capa board members discussed potential root causes of the complaints.One of the root causes may be the use error of the improper storage of administration sets, which compromised the sterility of sets.The other potential root cause may be the side effects of using taxol and opdivo.A comprehensive health risk assessment has been performed using fda's health hazard evaluaiton (hhe).The overall probability that causing adverse health consequence by the zyno administration sets is remote.The pouch label of the zyno administration sets clearly indicates: "sterile unless package has been opened or damaged".Zyno medical sent an email to the distributor and emphasized that opening the pouch 1-2 days prior to use could comprised the sterility of the sets.In the email, zyno medical highly recommend the distributor to communicate with this customer that this type of practice should be terminated.
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Event Description
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A distributor reported an issue of administration sets to zyno medical on 11/06/2019: "on (b)(6) 2019, (b)(4) of zyno solutions received a email from (b)(6).(b)(6) stated that an administration set model#: b2-70071-df; lot#: 19066538, patients were having strange reactions to chemos that they were previously fine with.Kasee stated this happened for roughly 25-30 infusions.They started adding a baxter filter to the end of the zyno tubing and this issue stopped.Operator rn.Medication taxol or opdivo.8 patients involved.8 patients were harmed, emergency medicine had to be administered to all 8 patients on multiple occasions.(b)(6) stated that once a patient had an anaphylactic reaction and they had to use epi to get her airway regulated.(b)(6) 2019." the distributor provided an update of the issue on 11/07/2019: "problems began in (b)(6) with patient's having reactions to taxol infusions and 1 patient had a reaction to opdivo (both infusions require a filter).Once the reactions kept happening, they took a further look at their practice to see if maybe the pre-meds had been given different.After re-analyzing their pre-med administration and seeing that it was the same process as it always was, patients were still having reactions.They then did some research to see what could cause reactions and they decided to take a look at the filtered sets.They confirmed they were using the 0.22micron filter and it was dehp free.After still having some reactions, they decided to take a b2-70071-d set and put on an extension filter and have not had a reaction since then.The add on extension filter they used was not one of ours.See estimated about 25% of filtered administrations were causing reactions, and did mention that they were finding some sets with the roller clamp upside down.I asked her to confirm what tubing they were using and what they currently have in stock and to elaborate a little more on the situations and she sent me the email that is below.What seems odd to me is that per my tracing reports they used the b2-70071-df but below she says it's the b2-70072-f." the distributor also forwarded the email from the user facility: "the most recent lot numbers of product#: b2-70072-f were 19046285 expires 04/16/2022, and 19066538 exp 6/19/2022.I clarified with the nurses that not all roller clamps were upside down.They said just one here or there in a box.Also, i was told occasionally the white part of the injection port was missing on a set of tubing.We didn't track these tubings from july because we had felt that somehow the pre-meds were the problem.When our nurses started using the regular tubing with an extension filter piece we stopped having the reactions.The reactions were with taxol and one patient with opdivo.When the filter was replaced with the extension filter with regular tubing even patients with prior reactions didn't react.The reactions were flank pain, shortness of breath, face reddened- treated with epi sq, solumedrol 100 mg iv, oxygen, and occasionally a patient was given iv demerol for rigors.No one had permanent sequelae." on 11/12/2019, the distributor forwarded the email from the user facility stating that "our review focused on the administration of pre-meds, timing, and dosages.We actually did a literature search and found a similar zyno lot number had a recall last year and also found an article where a center found increased infusion reactions when using pumps for infusions.Collectively we thought maybe the problem was the filters so we trialed using the regular zyno pump tubing and added a separate 0.22 micron dehp/pvc free filter (compatible with taxol).Every single patient who was re-administered taxol did not react to this method.That was when we concluded we would not use zyno filter tubing and administer by adding a separate filter when administering taxol.As far as documentation for these patients who have reacted, they have reactions and treatment for such documented." zyno medical requested the distributor to ask the user facility what corrective actions had they conducted after reviewing the "administration of pre-meds, timing, and dosages" and clarified that the previous recall on the b2-70071-df was related to a potential filter leaking issue for specific lots.Later at the same day, the distributor forwarded the email from the user facility "the adjustments we made were with changing the premed dexamethasone (10 mg iv) to solumedrol (100 mg iv).The other premeds administered were akynzeo or aloxi & emend, benadryl 25 mg iv, and pepcid 10 mg iv.Since the premeds take at leas an hour to administer we were administering the taxol right after the pre-meds, then when reactions started the physician decided to have nursing wait 30 minutes after all premeds started before giving the taxol.(this didn't make a difference in the frequency and recurrence of reactions).".
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Event Description
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This is a follow-up for the initially filed mdr (3006575795-2019-00031).
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Manufacturer Narrative
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Zyno medical received two investigation reports from the contract manufacturer on 02/28/2020 and 03/19/2020 respectively.One investigation report is about the roller clamp upside down issue and the other is about the filter not working issue.The investigation results from the two reports are summarized below: 1.Investigation on the roller clamp upside down issue: the contract manufacturer performed a trend review for model b2-70071-df and no additional qns or complaints related to "roller clamp upside down" failure mode were found in a 12-month period.The contract manufacturer determined that the most probable cause of this issue was due to operator not using the fixture that allows to ensure the correct orientation fo the roller clamp.The contract manufacturer stated that the quality alert to reinforce good manufacturing practices and usage of roller clamp fixture was sent by the production supervisors.No additional corrective or preventive actions was considered since it was found to be an isolated situation with no negative trend in last 12 months, however it will be monitored for track and trend to prevent any other recurrence.2.Investigation on the filter not working issue: the contract manufacturer performed a trend review for model b2-70071-df and no additional qns or complaints related to "filter not working" failure mode were found in a 1-year period.The contract manufacturer conducted the filter functional testing for the 25 samples of the 150 returned administration sets from the same lots as the affected devices.No occlusion or leak were detected.The reported failure mode was also reviewed from the clinical perspective, since the usage of medication was involved.This failure mode was reviewed by bd clinical operations.According with their findings and the information from the customer, the medication will always have some reaction due to the drug itself, so there is no way to prove if this was a filter issue or a drug lot issue since the lot of the drug is already used and the issue is most likely stopped.Therefore, the failure mode could be related to the drug administration and usage.The contract manufacturer stated that no immediate, corrective or preventive actions were required due to the failure mode is not related to the manufacturing process.They will continue to monitor their customer feedback processes for any similar incidences, implement any corrective actions as appropriate.
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Search Alerts/Recalls
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