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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0007
Device Problem Infusion or Flow Problem (2964)
Patient Problems Apnea (1720); Low Blood Pressure/ Hypotension (1914)
Event Date 09/17/2020
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the gem 20dp ckv 3ss dehp free was involved with a case of overinfusion, resulting in a serious injury to the patient. The patient continued being administered medication despite the pump being switched off, resulting in an apneic episode. The patient experienced sporadic breathing and a loss in blood pressure as a result. Medical staff disconnected the medication from the patient's iv, causing the patient's blood pressure and breathing to return to normal. The following information was provided by the initial reporter: material no: (b)(4), batch no: unknown. The patient had been receiving a propofol infusion during the duration of the case. Towards the end of the case, the infusion was stopped. Prior to discontinuing the infusion, the patient was noted to be breathing spontaneously, and blood pressure was rising. 2 minutes later, the blood pressure was noted to be low (70s/40s) and patient noted to go apneic (stopped spontaneously breathing). Positive pressure ventilation was initiated (through an lma already in place) and vasopressors were administered to raise blood pressure. Next blood pressure was again low, and patient remained apneic. A few minutes later, while still treating hypotension, the propofol bottle that had previously been stopped was noted to be dripping at a steady rate, and propofol was noticed to be going into the iv tubing, into the patient. The propofol tubing was disconnected from the patient's iv, and the propofol was noted to continue to drip from the end of the tubing, despite the fact that it was still stopped on the pump. The pump never alarmed, and as far as a i know was delivering the appropriate dose during the case. I had multiple people in the room observe the pump, and confirm that it was stopped, yet still dripping propofol. After prop was disconnected, patient's blood pressure slowly began to return to baseline, and spontaneous respirations returned about 20 minutes later. In all, i suspect the patient received a 500mg bolus of propofol over a period of 3-4 minutes. Patient was extubated in the room, and was noted to be back to neurological baseline in the pacu 1 hour later.
 
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Brand NameGEM 20DP CKV 3SS DEHP FREE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10793506
MDR Text Key216660826
Report Number9616066-2020-20258
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot NumberUNKNOWN
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 Received11/24/2020
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: 11/05/2020 Patient Sequence Number: 1
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