MAUDE Adverse Event Report: MEDOS SARL MEDSTREAM CONTROL UNIT

Catalog Number	914205
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).Information regarding patient weight, race, ethnicity, and medical history were not provided.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (ckcdt2) from serial #(b)(4) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformance's related to device manufacture or inspection.The product conformed to specifications when it was released.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that the medstream control unit (914205 / serial#: (b)(4) / lot# cdcdt2) was defective; the control unit suspends the programming process.It was reported that the device was able to communicate with the medstream pump and likely that the issue was related to the battery as the device was loaded regularly.The programming was correct but then drops out.There was no disruption of the baclofen treatment as the sales representative had another control unit available and this unit did not have any programming limitation.There was no report of any patient injury related to the reported event with the control unit.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report that the medstream control unit is no longer available for return.[conclusion]: the healthcare professional reported that the medstream control unit (914205 / serial#: (b)(6) / lot# cdcdt2) was defective; the control unit suspends the programming process.It was reported that the device was able to communicate with the medstream pump and likely that the issue was related to the battery as the device was loaded regularly.The programming was correct but then drops out.There was no disruption of the baclofen treatment as the sales representative had another control unit available and this unit did not have any programming limitation.There was no report of any patient injury related to the reported event with the control unit.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (ckcdt2) from serial #(b)(6) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.The product conformed to specifications when it was released.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed with the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The complaint documented that the issue was likely related to the battery and the defective control unit was replaced by the sales representative.There was no disruption to the baclofen therapy.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: MEDSTREAM CONTROL UNIT
• Common Device Name: MEDSTREAM
• Manufacturer (Section D): MEDOS SARL; rue girardet 29; le locle jura CH-24 00; SZ CH-2400
• MDR Report Key: 8624505
• Report Number: 8031062-2019-00514
• Device Sequence Number: 1654738
• Product Code: LKK
• UDI-Device Identifier: 10886704064947
• UDI-Public: 10886704064947
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2009
• Device Catalogue Number: 914205
• Device Lot Number: CKCDT2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1