• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 300865
Device Problems Complete Blockage (1094); Inappropriate Audible Prompt/Feedback (2280)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 2002299. Medical device expiration date: 2025-01-31. Device manufacture date: 2020-03-02. Medical device lot #: 2002284. Medical device expiration date: 2025-01-31. Device manufacture date: 2020-02-21. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
Event Description
It was reported that two syringes 50ml ll experienced the syringe pump alarming during use, clogged/blocked needles, and a serious injury, medical intervention. The product defects were noted during use. The following information was provided by the initial reporter: patient arrived from cardiac theatres at 19:15 16. 6. 20 following cabgx4. Initially patient haemodynamically stable. At around 20:00 patient spontaneously dropped blood pressure to 60-70 systolic- iv fluid boluses given and noradrenaline increased. At approx. 20:30 patient significantly dropped bp again to 50-60 systolic and norad pump alarmed 'occlusion'. Again, iv fluid given and norad increased. Nurse in charge advised to change noradrenaline syringe at this point as recent similar incidents had happened with other patients on the unit relating to noradrenaline. I drew up another syringe of noradrenaline, new electrocath, pump and lumen on the cvc was used. Patient continued to be haemodynamically unstable overnight and on numerous times dropped blood pressure but norad pump did not alarm. The patient was then treat as hypovolaemic and iv fluid (4l) was given overnight. At approx. 04:10 patient again significantly dropped bp to 30 systolic- inadequate cardiac output but no change to ecg trace on monitor. Approx 30 seconds of cpr commenced and iv fluid given. Norad pump then alarmed 'occlusion' again. Metaraminol boluses given by anesthetist and patient bp rose to 60-70 systolic and remained like this until approx 04:30. Norad syringe, pump, line and lumen changed again. Patient then remained stable until the end of my shift at 07:30. Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) as stated in description, norad pump, syringe, line and lumen on cvc was changed at each time pump alarmed 'occlusion'. Anesthetist surgeon was contacted and aware of patients instability regularly overnight and patient was reviewed by surgeon when bp dropped. Cxr performed at approx 22:00 and echo performed at 04:30. Nurse in charge aware of patient overnight and clinical educator informed in the morning to conduct investigation. Syringe changed and patient stabilised. All syringes with batch numbers 2002299 & 2002284 removed.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceSYRINGE
Manufacturer (Section D)
camino de valdeolivia
san agustin de guadalix
Manufacturer (Section G)
camino de valdeolivia
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key10279751
MDR Text Key200458739
Report Number3003152976-2020-00308
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/15/2020 Patient Sequence Number: 1