MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MEDSREAM PUMP 20 ML; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Catalog Number 914200

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This initial mdr will be the only report submitted for mfr report #3008114965-2018-00759.Additional patient and event information has been requested; however, a response has not yet been received.Additional initial reporter information has been requested; however, a response has not yet been received.Additional information will be provided within 30 days of receipt.

Event Description

It was reported by a healthcare professional that a patient had been receiving audible alarms from a medstream drug pump (914200/nmbj8f) since 5am.The patient's next refill date was scheduled for a week later.

Manufacturer Narrative

Product complaint # (b)(4).This final mdr will be the only report submitted for mfr report #3008114965-2018-00759.Additional information received on october 22, 2018: the patient experienced a minimal increase in pain, but was very attentive.The patient's pain was reported to be a 6 on the visual analog scale (vas) of pain, otherwise a 3.T he pump was implanted on (b)(6) 2013.The patient's last refill procedure was on (b)(6) 2018.Morphine was being administered through the pump at 1.4mg/24h.No side effect were experienced.A procedural delay of less than 30 minutes was reported.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.It was noted that the physician missed the patient¿s pump refill date.The pump alarmed when it was low.The device is working as intended.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MEDSREAM PUMP 20 ML
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 7930573
• MDR Text Key: 122649397
• Report Number: 3008114965-2018-00759
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 914200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Patient Sequence Number: 1