ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
Report
- Report Number
- 3006575795-2022-00002
- Event Type
- Injury
- Date Received
- February 15, 2022
- Date of Event
- November 19, 2021
- Report Date
- March 16, 2022
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- PMA / PMN Number
- K130690
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ZYNO MEDICAL HAS CONTACTED THE END USER TO FOLLOW UP FOR MORE INFORMATION AND IS STILL WAITING FOR RESPONSE.
ZYNO MEDICAL HAS CONTACTED THE END USER TO FOLLOW UP FOR MORE INFORMATION AND IS STILL WAITING FOR RESPONSE.
ZYNO MEDICAL CONTACTED THE END USER REGARDING THE DEVICE RETURN STATUS ON 02/04/2022, 02/09/2022 AND 02/25/2022 BY EMAIL AND PHONE CALLS. NO RESPONSE WAS RECEIVED FROM THE END USER. THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION. NO INVESTIGATION COULD BE PERFORMED. NO ROOT CAUSE COULD BE ESTABLISHED.
ON 02/03/2022, ZYNO MEDICAL RECEIVED A LETTER FROM FDA (MW5106399). A NURSE CONTACTED FDA ON 12/28/2021 AND REPORTED THAT: "EVENT TRANSPIRED IN AN INFUSION SUITE. PT HAD RECEIVED THIS MEDICATION 3 TIMES PRIOR TO THIS VISIT. PT WAS GIVEN INFLECTRA 400MG VIA PIV ON (B)(6) 2021 AT A SLOWER RATE OF 75ML/HR D/T PT HAVING SOME NAUSEA THE LAST INFUSION. PT HAD TAKEN ORAL BENADRYL 25MG PO AND 500MG PO TYLENOL PRIOR TO INFUSION 30MIN. PT WAS ISSUING IN CHAIR AND WATCHED CAREFULLY BY INFUSION RN. INFUSION WAS STARTED AT 1515 AND BY 1523 PT STARTED TO HAVE TROUBLE BREATHING AND C/O CHEST DISCOMFORT. INFUSION WAS STOPPED AND PT HAD BY THIS TIME TURNED "PURPLE". PT BEGAN TO VOMIT AS RN CALLED 911 WHILE ADMINISTERING 1 MG EPINEPHRINE IV AND OPENING NS FLUIDS WIDE TO THE PT'S PIV. PT WAS ALSO GIVEN 25MG IV DIPHENHYDRAMINE. EMS ARRIVED BY 1528 AND PT HAD RECOVERED BY THAT POINT AND STOPPED VOMITING AND WAS ABLE TO BREATH AND DENIED ANY CHEST DISCOMFORT. PT WAS TAKEN TO LOCAL HOSPITAL ED AND EVALUATED FOR 5 HOURS POST EPISODE TO MAKE SURE PT DID NOT HAVE ANY FURTHER DISTRESS OR ANAPHYLAXIS REBOUND. PT'S MOTHER KEPT IN TOUCH WITH RN AND PT WAS DOING WELL BUT SLEEPY FROM THE BENADRYL. MD WAS NOTIFIED AS WELL AS ADMIN TEAM AND PHARMACY. FDA SAFETY REPORT ID#(B)(4)." THE EVENT WAS REPORTED AS "ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM". THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS INFLECTRA. THE PATIENT HAD SYMPTOMS OF CHEST PAIN, DYSPNEA, ALLERGIC REACTION, SKIN DISCOLORATION AND VOMITING.
ON 02/03/2022, ZYNO MEDICAL RECEIVED A LETTER FROM FDA (MW5106399). A NURSE CONTACTED FDA ON 12/28/2021 AND REPORTED THAT: "EVENT TRANSPIRED IN AN INFUSION SUITE. PT HAD RECEIVED THIS MEDICATION 3 TIMES PRIOR TO THIS VISIT. PT WAS GIVEN INFLECTRA 400MG VIA PIV ON (B)(6) 2021 AT A SLOWER RATE OF 75ML/HR D/T PT HAVING SOME NAUSEA THE LAST INFUSION. PT HAD TAKEN ORAL BENADRYL 25MG PO AND 500MG PO TYLENOL PRIOR TO INFUSION 30MIN. PT WAS ISSUING IN CHAIR AND WATCHED CAREFULLY BY INFUSION RN. INFUSION WAS STARTED AT 1515 AND BY 1523 PT STARTED TO HAVE TROUBLE BREATHING AND C/O CHEST DISCOMFORT. INFUSION WAS STOPPED AND PT HAD BY THIS TIME TURNED "PURPLE". PT BEGAN TO VOMIT AS RN CALLED 911 WHILE ADMINISTERING 1 MG EPINEPHRINE IV AND OPENING NS FLUIDS WIDE TO THE PT'S PIV. PT WAS ALSO GIVEN 25MG IV DIPHENHYDRAMINE. EMS ARRIVED BY 1528 AND PT HAD RECOVERED BY THAT POINT AND STOPPED VOMITING AND WAS ABLE TO BREATH AND DENIED ANY CHEST DISCOMFORT. PT WAS TAKEN TO LOCAL HOSPITAL ED AND EVALUATED FOR 5 HOURS POST EPISODE TO MAKE SURE PT DID NOT HAVE ANY FURTHER DISTRESS OR ANAPHYLAXIS REBOUND. PT'S MOTHER KEPT IN TOUCH WITH RN AND PT WAS DOING WELL BUT SLEEPY FROM THE BENADRYL. MD WAS NOTIFIED AS WELL AS ADMIN TEAM AND PHARMACY. FDA SAFETY REPORT ID#(B)(4)." THE EVENT WAS REPORTED AS "ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM". THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS INFLECTRA. THE PATIENT HAD SYMPTOMS OF CHEST PAIN, DYSPNEA, ALLERGIC REACTION, SKIN DISCOLORATION AND VOMITING.
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1844762 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |