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

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.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that the pump was stopped, propofol tubing was disconnected from the patient's iv, and the propofol was noted to continue dripping from the end of the tubing.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

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: 2426-0007 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.

• Brand Name: GEM 20DP CKV 3SS DEHP FREE
• Type of Device: INTRAVASCULAR 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
• MDR Report Key: 10793506
• MDR Text Key: 216660826
• Report Number: 9616066-2020-20258
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• 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 Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention