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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 Pumping Stopped (1503); Volume Accuracy Problem (1675); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath, serial#: unknown, implanted: (b)(6) 2018, product type: catheter. Product id: 8731, serial#: unknown, product type: catheter. Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown; product id: 8731, serial/lot #: unknown. Initial reporter occupation: healthcare professional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine 20 mg/ml at 4,5 mg/day via an implantable pump. The indication for use was not reported. It was reported a volume discrepancy occurred at the patient¿s last refill in (b)(6) 2018. The hcp attempted to aspirate the catheter via the sideport; there was no cerebrospinal fluid (csf) [flow]. The catheter was disconnected from the pump; there was no csf [flow]. In the back, the catheter connection (8731) was found and disconnected; there was no csf [flow] from the spinal segment. The decision was made to change the entire catheter. Elective replacement indicator (eri) was at 12 months, and the healthcare professional (hcp) decided to replace the pump as well. The pump would be returned to the device manufacturer with part of the catheter still attached to it. It was unknown if the issue was resolved. However, the patient's status was alive - no injury. There were no applicable environmental, external or patient factors reported that might have led or contributed to the event. The implant date, event date, patient age, patient weight, and medical history were unknown. Additionally, logs showed a motor stall occurred on (b)(6) 2018 at 15:21 with recovery on (b)(6) 2018 at 16:11. No patient symptoms were reported. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Pump analysis found overinfusion (undetermined root cause). Neu_unknown_cath analysis found no significant anomalies, 8731 catheter analysis found no significant anomalies method code applies to the pump, neu_unknown_cath, and the 8731 catheter result code applies to the pump, result code applies to neu_unknown_cath and the 8731 catheter; conclusion code applies to the pump, conclusion code applies to neu_unknown_cath and the 8731 catheter. 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 Key7727182
MDR Text Key115256513
Report Number3004209178-2018-16840
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2018
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 Manufactured06/25/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 07/27/2018 Patient Sequence Number: 1
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