MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. DRESSING; OMP

Model Number VACDSP

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 12/01/2020

Event Type  Death  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the patient expired due to tripping over the v.A.C.® tubing of the activ.A.C.¿ therapy system.The physician stated the patient had multiple co-morbidities as well as a history of falls in the house due to peripheral neuropathy and doubted the fall was the cause of the death.Device labeling, available in print and online, states: fall safety prevention tips the following safety tips should be used to help prevent a patient falling or slipping while using the v.A.C.® therapy unit: be cautious of door knobs and other household objects that could catch on exposed tubing.Safely store excess electrical cord and any extra tubing and secure it to prevent tripping (see therapy unit instructions on how to properly secure tubing).Activ.A.C.¿ therapy system user manual: to reduce the risk of serious or fatal injury, all caregivers and patients must carefully read and follow all user instructions and safety information that accompany kci products.The activ.A.C.¿ therapy system may present a tripping hazard if placed on the floor.Ensure that the activ.A.C.¿ therapy unit is not placed in areas where people may walk.

Event Description

On (b)(6) 2020, the following information was reported to kci by the nurse: this patient is allegedly deceased due to tripping on the v.A.C.® tubing and falling.On 10-dec-2020, the following information was reported to kci by the treating physician: the physician "doubted the fall was the cause of the patient death." this patient had multiple co-morbidities as well as a history of falls in the house due to peripheral neuropathy.The patient wore a boot on his other foot due to additional wounds and refused to use his walker.The physician suspects the patient died of an arrythmia as he has a history of cardiac issues.No additional information available.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.

Manufacturer Narrative

Mdr: 3009897021-2020-01069 submitted on 23-dec-2020 noted the following: d1: brand name: activ.A.C.¿ therapy system.D4: model#: wndact; catalog#: 340020; unique identifier (udi)#: (b)(4).G4: premarket identification pma/510(k): 201571.H4: device manufacture date: 14-apr-2016.H5: labeled for single use?: no.H8: usage of device: reuse.Corrections: d1: brand name: v.A.C.® therapy dressing.D4: model#: vacdsp; catalog#: ni; unique identifier (udi)#: ni.G4: premarket identification pma/510(k): k063692.H4: device manufacture date: blank.H5: labeled for single use?: yes.H8: usage of device: initial use of device.Additional information regarding the activ.A.C.¿ therapy system serial number: (b)(6): d4: unique identifier (udi)#: (b)(4); section h4: device manufacture date: 14-apr-2016.Section h3: other (code unspecified, describe in h10): the v.A.C.® dressing type and identifier were not provided.Based on the corrections and additional information provided obtained regarding the v.A.C.® dressing , kci's assessment remains the same; it cannot be determined that the patient expired due to tripping over the v.A.C.® dressing tubing of the activ.A.C.¿ therapy system.The v.A.C.® dressing identifiers were not provided and the activ.A.C.¿ ion progress¿ remote therapy monitoring system passed quality control checks before and after patient placement.The physician stated the patient had multiple co-morbidities as well as a history of falls in the house due to peripheral neuropathy and doubted the fall was the cause of the death.

Event Description

On 28-jan-2021, quality engineering completed an evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system.On 21-aug-2020, the device was tested per quality control procedure by kci field service, and the unit passed the quality control checks and met specifications.On (b)(6) 2020, the device was placed with the patient.On 26-jan- 2021, the device was tested per quality control procedure by kci quality engineering and passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction of the unit.The v.A.C.® dressing lot number was not provided and is not available for return, therefore, a device history review and a device evaluation could not be performed.

• Brand Name: V.A.C. DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 11070185
• MDR Text Key: 223576204
• Report Number: 3009897021-2020-01069
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Catalogue Number: 340020
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARVEDILOL 25 MG TABLETS TWICE DAILY.; ELIQUIS 5 MG TABLET TWICE DAILY.; ENTRESTO 24 MG TWICE DAILY.; HYDROCODONE 5 MG.; PRAVASTATIN 40 MG TABLIETS DAILY.; TOUJEO MAX U-300 20 UNITS DAILY.; CARVEDILOL 25 MG TABLETS TWICE DAILY; ELIQUIS 5 MG TABLET TWICE DAILY; ENTRESTO 24 MG TWICE DAILY; HYDROCODONE 5 MG; PRAVASTATIN 40 MG TABLIETS DAILY; TOUJEO MAX U-300 20 UNITS DAILY
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 103