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Model Number B2-70071-DF
Device Problems Improper Chemical Reaction (2952); Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Patient Problems Hypersensitivity/Allergic reaction (1907); Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
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)
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.
Event Description
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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Manufacturer (Section D)
177 pine street
natick MA 01760
Manufacturer (Section G)
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
MDR Report Key9359118
MDR Text Key216641786
Report Number3006575795-2019-00031
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70071-DF
Device Catalogue NumberB2-70071-DF
Device Lot Number19066538
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial