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Model Number 1186000777
Device Problem Physical Resistance/Sticking (4012)
Patient Problems Low Blood Pressure/ Hypotension (1914); No Code Available (3191)
Event Date 03/04/2020
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device from the incident will not be returned for evaluation because it was discarded but a representative sample will be provided for evaluation however to date the representative sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. (b)(4).
Event Description
The customer reported that a nurse was trying to pull blood from a child and was only able to fill 30cc. The nurse had to switch syringes and the second time was only able to pull 35cc. In one instance they had to switch the syringe three times which subjects the patient to multiple levels of infection. The clinical team also noted that the flange seems different in appearance and for some reason there is a great deal of resistance when you go to first use the product. They stated that they cannot completely pull out the flange to release the air lock as this would open the device for infection. Additional information received on 5-mar-2020 stated that the patient was an h1n1 patient on ecmo that needed rapid fluid and blood resuscitation to prevent arrest and they were unable to use the 60 ml monoject syringes to rapidly push volume or blood into the patient. Several rn, apn and intensivist (male and female) attempted to push ns or blood into high volume tubing into distal ports of central line and it was nearly impossible to push any of this volume out for delivery to the patient. This incident was not on pumps. They were all manual pushes. The syringe is very sticky and appears to be less lubricated or too tight for the diameter. When they have some svr or tubing resistance they cannot get the plunger to push forward. They tried multiple syringes and every time they ended up using a bd syringe instead, using the same tubing and line and were able to get the fluids/blood to the patient. When the patient was coming off ecmo they were unable to give her her volume when her pressures tanked (hemodynamic instability) and they had to go back on the ecmo circuit until they could get her blood volume another way before coming off successfully 30 minutes later. The bedside rn expressed frustration that she was pulling up washed packed red blood cells out of an aliquot or wheel of blood. She was using the 60 ml monoject syringe attached to their blood filter and then to an 18g needle inserted into the blood spike. Three syringes in a row using all of the nurse¿s strength she could only get the 60 ml syringes filled to the 30-35 ml range. They had her keep her blood filter and throw on another type of syringe to see if it was the blood filter and she was able to rapidly fill this entire syringe without needing to exert so much strength. On (b)(6) 2020 the customer also stated that patient had hypotension, low cvp¿s, low cardiac perfusion which describes the need for fluid resuscitation. The customer cannot recall the required volume of blood or fluids. Multiple blood pushes were given; the customer reported that they usually start 10 ml/kg for cardiac and 20 ml/kg for non-cardiac.
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Manufacturer (Section D)
1222 sherwood road
norfolk NE 68701
Manufacturer (Section G)
1222 sherwood road
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
MDR Report Key9922692
MDR Text Key195278961
Report Number1915484-2020-01145
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1186000777
Device Catalogue Number1186000777
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/03/2020 Patient Sequence Number: 1