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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Pain (1994); Tachycardia (2095); Ventricular Fibrillation (2130); Toxicity (2333); Loss Of Pulse (2562)
Event Date 12/08/2016
Event Type  Death  
Manufacturer Narrative
The pump was returned for analysis. Analysis identified overinfusion due to an undetermined root cause and residue on the gear shaft of the motor gear train that resulted in the motor stall. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Device returned with no return paperwork. The pump was returned to the manufacturer without a complaint. No patient symptoms or complication were reported as a result of this event. Additional information was received from a healthcare provider (hcp) indicated that the patient had dies due to multifactorial causes which included possible baclofen toxicity. No autopsy was performed. On (b)(6) 2016, the patient was seen by their pump physician for a pump refill and there were no issues with volume discrepancies or issues observed in the logs upon pump interrogation. On (b)(6) 2016, the patient returned to their pump physician due to increased spasms that were increasing in intensity. The pump was increased 5% at that time, but it did not help and spasms continued; the pump was infusing baclofen and morphine at that time. The patient went in to the emergency department on (b)(6) 2016 and was treated with intravenous morphine for pain and oral baclofen and valium for their spasms. The patient subsequently dropped their blood pressure and was treated with vasopressin and epinephrine. At some point, the patient was admitted to the icu. The patient lost their pulse, went into ventricular tachycardia and ventricular fibrillation. The hcp stated that there was no information provided to suggest that it was due to the pump. The patient was defibrillated several times, but passed away on (b)(6) 2016. The hcp again stated that there was nothing in the patient chart to indicate that there was a problem with the pump, but did state that one possible cause of death was possible baclofen toxicity. No additional information was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7731465
MDR Text Key115393066
Report Number3004209178-2018-16914
Device Sequence Number0
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2012
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: 07/30/2018 Patient Sequence Number: 1
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