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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Failure To Service (1563); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

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

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 healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving dilaudid, 7.5 mg/ml concentration at 4.9914 mg/day and bupivacaine, 23 mg/ml concentration at 15.307 mg/day via intrathecal drug delivery pump for unknown indication of use.It was reported that the hcp scheduled replacement without disclosing the alarm status.The rep found alarms on preorder interrogation.No environmental/external/patient factors that may have led or contributed to the issue was known.The rep did not know clinic evaluation.For intervention, pump replacement occurred and catheter aspirated easily.The rep arrived to pump replacement and interrogated the pump preposition.Empty reservoir alarm was active, motor stall alarm was active and motor stall exceeding tube set was active.Pump log was attached: multiple motor stall and recovery was reported.At the time of this report, the issue was resolved and patient status was alive-no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from manufacturer representative (rep).It was reported that the information was obtained today.Patient's weight was (b)(6) lbs.Patient's medical history included post lumbar lami and spinal stenosis.On (b)(6) 2017, patient was admitted to hospital and hospital let pump go dry.On (b)(6) 2017, the rep went to the hcp and interrogated and a couple motor stall and recoveries were note.Patient was admitted to rehab facility before replacement.No further complications were reported.

Manufacturer Narrative

The pump was returned and analysis found pump/motor/gear train anomaly/corrosion and-or wear and-or lubrication and pump/motor/m otor/gear train anomaly/stall due to shaft-bearing.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.

• 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: 7510883
• MDR Text Key: 108151934
• Report Number: 3004209178-2018-10803
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 105