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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Volume Accuracy Problem (1675); Intermittent Infusion (2341)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign health care provider (hcp) via a manufacturer representative regarding a patient who received hydromorphone (12.5mg/ml, 8.210mg/day) and bupivacaine (15mg/ml, 9.853mg/day) in an implantable pump for an unknown indication for use.The patient medical history and concomitant medications were unable to be obtained.The patient presented to a planned refill appointment on (b)(6) 2018 and told the hcp an audible alarm was heard for several days.The patient did not experience any underdose symptoms.There were no known environmental/external/patient factors that may have led or contributed to the issue.No troubleshooting/actions/interventions were currently planned.The provided interrogation print report indicated a motor stall occurred on (b)(6) 2018 at 11:50 with a stopped pump may exceed tube set message on (b)(6) 2018 at 11:50.A recorded motor stall recovery occurred on (b)(6) 2018 at 20:03.It was noted the expected reservoir volume (erv) was 4.6ml and the actual reservoir volume (arv) was 9.0ml.The patient was to contact the hcp if the alarm recurred.The issue was considered resolved at the time of the report.The pump remains implanted-in service.The status of the patient was stated to be alive and with no injury.The next refill appointment was scheduled for (b)(6) 2018.No complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign hcp via a manufacturer representative on 2018-jun-07.It was reported there was no suspected cause for the motor stall and that at the time of the report, it was not likely any further actions would be taken to resolve the issue.The patient was at home and fine with no critical alarm.No complications were reported or anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the pump revealed pump motor gear train anomalies.These included corrosion and/or wear and/or lubrication and stall due to shaft-bearing.(b)(4).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 was received on 2018-jun-29.It was reported that the patient came to the hospital on 2018 (b)(6) because of a critical alarm.The log files showed again a motor stall since 2018 (b)(6).The patient had no withdrawal symptoms.The doctor changed the pump on 2018 (b)(6).It was noted the doctor could aspirate some liquor and they didn' t changed the catheter.At the time of the report, the patient was fine.The pump would be returned.Pump logs were included with the report and showed the following events: motor stall occurred 2018 (b)(6) at 11:52 stopped pump duration may exceed "tube set" 2018 (b)(6) at 11:52 motor stall recovery occurred 2018 (b)(6) at 20:05 motor stall occurred 2018 (b)(6) at 13:29 no further complications were reported or anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7558071
• MDR Text Key: 109905018
• Report Number: 3004209178-2018-12283
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR