MAUDE Adverse Event Report: CORK MEDICAL LLC NISUS; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number CMPP-100

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

From complaint investigation: complaint: (b)(4).Date received: (b)(4) 2020.Investigation date: (b)(4) 2020.Cmp was notified of the pump incident on 11/30/2020 by our distributor in oman, imtnan medical.Pictures were provided which appeared to show that the rear housing of the pump was exposed to the atmosphere.Quality & regulatory received the pump on 12/14/2020 and confirmed the suspicion from the photos that melting had occurred from the battery short causing exposure to the atmosphere.No battery information could be read from the pack as it was incinerated, but we were abel to trace the pump serial number to determine the pump build date of 08/14/2019 to find the record for completed test during the build of the pump.Only visual inspection was feasible; the unit smelled of an electrical burning, with a hole in the rear housing in the shape of the battery pack, with surrounding plastic metled.(b)(4) scheduled an interview with the reporter of the incident, (b)(4) on 12/22/2020.Although he has only been working with cmp for approximately 15 months, (b)(4) has been in negative pressure wound therapy for 10+ years and therefore declined training during distributor onboarding with cmp.Typically imtnan medical pumps are with patients from 2 to 6 months, with the allegation occurring during the 2nd month with a patient.During the incident the pump was disconnected from the patient and was connected to the power cord.The pump was being used in a patient home under the supervision of a healthcare center with a nurse completing application of therapy.When the pump is returned to imtnan after therapy is completed, the distributor cleans the device and confirmation of pump and battery function is completed.At the time of the event, the pump was approximately 14 months into its 5 year lifetime and had no preventive maintenance performed by imtnan.Preventive maintenance is recommedned for all pumps on an annual basis and distributors have the choice of returning the device to cmp for servicing or requesting a pm kit to complete the action internally.Risk assessmend of the complaint referenced the internal risk management procedure and included a severity of 3 and probability of occurrence of harm of 3, creating an rpn of 9, with the requirement to open a corrective action.As this allegation is a reoccurrence, a capa has already been opened, capa (b)(4) and was a collaboration between the cmp and the battery manufacturer fedco.A root cause was identified and implementation of the corrective action occurred in may of 2020.As this pump was built prior to implementation of this corrective action, no further action is required.Cmp will work with the distributor to complete device training and stress the importance of preventive maintenance to the pump.The pump was replaced, and new batteries were provided for the other pumps owned by the distributor to include the corrective action completed on 2019-020.

Event Description

A nisus pump was returned with a complaint alleging that the battery malfunctioned causing the pump to be inoperable.No injuries or harm were reported as the pump was disconnected from the patient.Due to the state of the device, no functional testing was feasble, but further visual inspection found melting of the rear housing occurred exposing the unit to atmosphere.Analysis of the device confirms the fault was likely the result of a short on the battery control board.This event has been reported to the manufacturer of the associated lithium batteries for further analysis.

• Brand Name: NISUS
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CORK MEDICAL LLC; 8000 castleway drive; indianapolis IN 46250
• Manufacturer (Section G): CORK MEDICAL LLC; 8000 castleway drive; indianapolis IN 46250
• Manufacturer Contact: allison stultz ; 8000 castleway drive; indianapolis, IN 46250 ; 3173614286
• MDR Report Key: 11089833
• MDR Text Key: 240776191
• Report Number: 3010588638-2020-00005
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00851675007005
• UDI-Public: (01)00851675007005
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: K140022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/29/2020

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
• Device Operator: No Information
• Device Expiration Date: 08/14/2024
• Device Model Number: CMPP-100
• Device Catalogue Number: CMPP-100
• Device Lot Number: 1932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1