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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 8637-40
Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional via a clinical study and a manufacturer representative on 04/27/2018 indicated the patient's baseline weight was (b)(6)kg. It was noted that there was no further information available at this time in regards to the pump explant/replacement. The cause of the volume discrepancy was not determined. The investigation was noted as ongoing. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative on (b)(6) 2018 regarding a patient receiving remodulin (10. 0mg/ml) via an implanted infusion pump. The indication for use was unknown. It was reported that on (b)(6) 2018, the actual volume was outside the expected volume accuracy. The expected volume was 8. 1ml and the actual volume was 16ml. There was no evidence of any associated clinical symptoms, and no adverse events were reported. Additional information received from healthcare professional via a clinical study and a manufacturer representative indicated on (b)(6) 2018 the actual volume was reported as outside the expected volume on the accuracy chart (unscheduled 35 visit). The expected residual volume (erv) was 0. 7ml and the actual residual volume (arv) was 10. 8ml. It was indicated there was a device malfunction for "flow accuracy rate not within expected range. " it was also noted that the patient was almost due for a pump replacement due to elective replacement indicator, so this was expected. There was no complaint from the patient. No actions were taken. The event date was noted to be (b)(6) 2018. No further complications were anticipated/reported.
 
Manufacturer Narrative
Interrogation of the pump determined it was used to infuse remodulin 10 mg/ml at 0. 061 mg/day. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that the pump was explanted and replaced on (b)(6) 2018. It was noted that there was no complaint associated with the device, and there was no patient death or patient injury. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study and a manufacturer representative indicated the patient's baseline weight was updated to (b)(6). On (b)(6) 2018 the flow accuracy rate was not within expected range. It was unknown if any actions were taken or if the patient experienced any associated symptoms. No patient complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study and a manufacturer representative indicated on (b)(6) 2018 the flow accuracy rate was not within the expected range where the programmer expected reservoir volume was 3. 6ml and the actual residual volume was 12ml. It was noted the patient did not have any symptoms. It was noted that no actions were taken and the event resolved. 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
MDR Report Key7477278
MDR Text Key107468256
Report Number3004209178-2018-09783
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P140032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

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