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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 No Audible Alarm (1019); Pumping Stopped (1503); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problems Abdominal Pain (1685); Burning Sensation (2146)
Event Date 04/27/2017
Event Type  malfunction  
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.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient who was receiving dilaudid 10 mg/ml; 1. 230 mg/day via an implantable pump. Indication for use was non-malignant pain. The date of the event was (b)(6) 2017. It was reported a pump motor stall was seen at initial interrogation. The logs revealed a stall occured on (b)(6) 2017 at 19:08 with recovery on (b)(6) 2017 at 00:19. A motor stall occurred on (b)(6) 2017 at 14:27 and stopped pump period may exceed tube set on (b)(6) 2017 at 14:27 (no recovery after that). The patient did not recently have magnetic resonance imaging (mri). There were multiple motor stalls and recoveries. The patient did not report hearing an alarm. The critical alarm interval was set to 1 hour. The patient did not have symptoms of withdrawal. The patient¿s diagnosis was ilioinguinal neuralgia. The patient did have a "burning sensation in the stomach" and abdominal pain last week which brought him to the hospital but those symptoms in no way line up with when the pump stalled. The patient had oral pain medication they take when needed but had not taken any recently. It was reviewed that the pump was in a hard stall and to confirm it was stalled, to aspirate from the reservoir. The hcp was expecting 25. 6 and got back 36 mls which was about what was calculated if the pump had been stalled since the end of (b)(6) 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 Key6727233
MDR Text Key100153583
Report Number3004209178-2017-15177
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 health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received07/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/13/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

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