MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD®-SOLIS POWER CORD; PUMP, INFUSION, PCA

Catalog Number	21-2145-01
Medical Device Problem Code	Charred (1086)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00679.
Event or Problem Description
It was reported that charring occurred on a cadd®-solis power cord used with a medfusion® 4000 wireless syringe infusion pump.The patient was moved to another room.No injury was reported.
Additional Manufacturer Narrative
One pump was returned for analysis in used condition.Visual inspection of the pump showed that the pump and the pump, power cord and power cord retainer were all badly burnt in and around the ac receptacle as a result of electrical shorting due to extensive fluid ingression.There was cracking found on the top case and left and right plunger cases as a result of chemical attack.There was impact damage to the front left top case corner with a piece of the top case missing.There was a lot of fluid residue found around the top case and bottom case seal.There was fluid ingression found inside the pump, but no evidence of fluid residue was found on or near the power supply assembly.Further investigation found that the customer introduced fluid to the surface of the power cord plug while plugged into the pump, which migrated via the plug's mold fixture holes into the interior of the power cord plug and shorted between the hot and ground leads at the base of their connectors.Testing and analysis was performed by an outside lab.It is speculated that the power cord plug may have had material voids inside that allowed fluid to connect the hot and ground leads.This is the first time that this type of failure (fluid ingression into the interior of the power cord plug) has been reported by a customer and observed by smiths.Based on the evidence, the complaint was confirmed.The root cause was attributed to the introduction of fluid to an electrical component.

• Brand Name: CADD®-SOLIS POWER CORD
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7350980
• Report Number: 3012307300-2018-00683
• Device Sequence Number: 723451
• Product Code: MEA
• UDI-Device Identifier: 10610586031342
• UDI-Public: 10610586031342
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: No Information
• Device Catalogue Number: 21-2145-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDFUSION® 4000 SYRINGE INFUSION PUMP