MAUDE Adverse Event Report: VR MEDICAL PRO-MINI; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	NP-1140-US
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) was notified by (b)(6) of an issue involving the pro-mini npwt device canister (finished good np-1140-us) leading to an internal complaint (call (b)(4)) being filed 10/23/2018.(b)(4) is a distributor of the vr medical pro-mini npwt device.(b)(4)'s customer, (b)(6), is also a distributor.(b)(4) was notified via email correspondence of the following incidence.A long term care facility was treating 2 patients with negative pressure wound therapy.During therapy, several times the "full canister alarm" would be triggered regardless of the amount of exudate within the canister.The product was not returned for evaluation.(b)(4) has requested the products in question (product code: np-1140-us; lot: ks1804033) for vr medical be returned.(b)(4) has removed remaining lot ks1804033 for np-1140-us from internal stock at (b)(4) facilities and is awaiting further disposition direction from vr medical.(b)(4) only shipped (b)(6) product from lot ks1804033.The complaint investigator reviewed the purchase order for possible discrepancies that may have contributed to the incidence.No discrepancies were found.On 10/25/2018, a supplier corrective action report was sent to vr medical for this issue.Vr medical replied to (b)(4) stating they acknowledged the malfunction and were completing an internal analysis to determine the root cause of the issue.Vr medical was able to trace the malfunction back to a single manufacturing lot of canisters, at a failure rate of 10%, which were being assembled outside of their specified range and attributed this to a manufacturer error caused by a new employee.Vr medical requested the canisters in (b)(4)'s possession be destroyed and has sent a replacement lot of canisters which they guarantee to be 100% within manufacturing specifications and which should not exhibit the same failures as the afflicted lot.(b)(4) will continue to monitor post market feedback and will recognize in the future if this issue reoccurs.The investigation is complete at this time.If new information is received, (b)(4) will take the necessary steps to update this information.
Event or Problem Description
A negative pressure wound therapy pump would register a "full canister alarm" even when the canister was not full.In this instance, there was no patient effect, but the potential for disruption to therapy may exist in the future.

• Brand Name: PRO-MINI
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): VR MEDICAL; no.90, gaoxin road; zhouzhuang, kunshan 21532 5; CH 215325
• MDR Report Key: 8109279
• Report Number: 2320762-2018-00013
• Device Sequence Number: 19374598
• Product Code: OMP
• UDI-Device Identifier: 50749756934782
• UDI-Public: 50749756934782
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: Health Professional
• Device Model Number: NP-1140-US
• Device Lot Number: KS1804033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1