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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

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

Event Date 05/29/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 241mcg/ml sufentanil at 50mcg/day, and 18.8mg/ml bupivacaine at 3.9mg/day via an implantable infusion pump for non-malignant pain and post-herpetic neuralgia.A pump alarm was reported by a hcp.It was reported that at a pump refill in march of 2017 the elective replacement indicator (eri) was still showing as 10 months away.The pump was read on (b)(6) 2017 and the eri occurred on (b)(6) 2017.The schedule to replace by date is noted as (b)(6) 2017.No symptoms were reported.No further complications were anticipated/reported.

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

Additional information was received from a healthcare provider (hcp).It was reported the pump was decreased for safety.The cause was reported to be due to the 2011 recall for battery performance.The premature elective replacement indicator (eri) had not been resolved and the patient may not have the pump replaced if they can be controlled with oral medications.The pump is still in the patient and the patient is being weaned off of the medications per the family's request.No further complications were anticipated/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 was received from a healthcare provider on (b)(6) 2018.It was reported that an pump alarm was heard and confirmed by telemetry.It was stated that they had electively programmed the pump to minimum rate mode and thought the pump was stopped.It was noted that the pump was delivering saline.It was reported that the pump was alarming, and upon interrogation, the pump status was showing that eos (end of service) and a reset had occurred in 2017.The caller requested and was provided the "pump off" code.It was reviewed that when the pump is eos, following the screen prompts and updating the pump will stop the alarming.It was noted that troubleshooting resolved the reported event.No patient symptoms were reported.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: 6620453
• MDR Text Key: 76959570
• Report Number: 3004209178-2017-11845
• Device Sequence Number: 1
• Product Code: LKK
• 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: health professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Date Device Manufactured: 04/14/2011
• 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-3043-2011
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 59