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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 Problems Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)
Patient Problems Sepsis (2067); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the health care professional via the manufacturers representative (rep) indicated that an explant occurred as scheduled for october 16, the rep would be sending the pump back to the manufacturer. There was no patient weight information. No further complications were anticipated/reported.
 
Manufacturer Narrative
Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer via a manufacturer's representative. It was reported that the patient had "other health issues" at the time of explant and due to her being septic, the system had to be removed. No further information was provided. No further complications were anticipated/reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the health care professional via the manufacturers representative indicated that the cause of low battery reset was elective replacement indicator (eri) as it was 2 months premature. Interventions/actions were noted as resetting of dosage and silencing of the alarms. The low battery reset issue had not been resolved as the alarms went off again. A pump replacement was scheduled for (b)(6) 2017, the pump would be returned for analysis. No further complications were anticipated/reported.
 
Manufacturer Narrative
Correction: updated if information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pump was returned, and analysis found high resistance in the battery. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the manufacturers representative and nurse regarding a patient who was receiving clonidine (concentration 127 mcg/ml, dose 22. 8 mcg/day) and morphine (concentration 20 mg/ml, dose 3. 598 mg/day) via an implantable pump. An alarm was heard and confirmed by telemetry, the critical alarm was due to low battery reset, reset occurred and safe state that occurred on the day prior to this report date. The pump logs were checked during the call. There were no symptoms reported. No further complications were reported.
 
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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 Key6922032
MDR Text Key101660506
Report Number3004209178-2017-20921
Device Sequence Number1
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 company representative,consum
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011

Patient Treatment Data
Date Received: 10/06/2017 Patient Sequence Number: 1
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